protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03595618 | 17.1.2 | Substantial protocol amendment and amended protocol | 17.1.2. Substantial protocol amendment and amended protocol If the protocol must be altered after it has been signed, the modification or substantial amendment must be discussed and approved by the coordinators and the sponsor. The substantial protocol amendment must be drafted in accordance with the sponsor standard o... | [] |
NCT03595618 | 17.1.3 | Final study report | 17.1.3. Final study report The study report will be drafted by I.R.I.S. in compliance with I.R.I.S. standard operating procedure and Galapagos requirements. The sponsors' representatives and the coordinators must mutually agree on the final version. One copy of the final report must be dated and signed by the coordinat... | [] |
NCT03595618 | 17.2 | Concerning the sponsor | 17.2. Concerning the sponsor The sponsor undertakes to: - supply the investigator with adequate and sufficient information concerning the IMP administered during the study to enable him/her to carry out the study, - supply the investigator with investigator's brochure if the study drug is not marketed, - obtain any aut... | [] |
NCT03595618 | 17.3 | Concerning the investigator | 17.3. Concerning the investigator | [] |
NCT03595618 | 17.3.1 | Confidentiality - Use of information | 17.3.1. Confidentiality - Use of information All documents and information given to the investigator by the sponsor with respect to S201086/GLPG1972 and study CL2-201086-002/GLPG1972-CL-201 are strictly confidential. The investigator expressly agrees that data on his/her professional and clinical experience is collecte... | [] |
NCT03595618 | 17.3.2 | Organization of the center | 17.3.2. Organization of the center The Investigator can delegate study tasks under his/her responsibility to others. Tasks can only be delegated to persons that are qualified to perform that specific task. An "Organization of center" or similar document needs to be completed for documentation purposes. This document sh... | [] |
NCT03595618 | 17.3.3 | Documentation supplied to the sponsor | 17.3.3. Documentation supplied to the sponsor The investigator undertakes before the study begins: - to provide his/her dated and signed English curriculum vitae (CV) or to complete in English the CV form provided by the sponsor or representative and to send it to the sponsor, together with that of his/her co-investiga... | [] |
NCT03595618 | 18 | REFERENCES | 18. REFERENCES Altman et al. Atlas of individual radiographic features in osteoarthritis, revised, Osteoarthritis and Cartilage (2007) 15, A1 - A56. Caselli et al. Effect Size of the Anti-Aggrecanase-2 Monoclonal Antibody CRB0017 in Rodent Models of Osteoarthritis, ACR/ARHP Annual Meeting, 2015. Chen P, Zhu S, Wang Y, ... | [
"Other regulatory references:"
] |
NCT03595618 | 19 | APPENDICES | 19. APPENDICES
Appendix 1: World Medical Association Declaration of Helsinki
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29th WMA General Assembly, Tokyo,... | [
"Appendix 1: World Medical Association Declaration of Helsinki",
"WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI",
"Ethical Principles for Medical Research Involving Human Subjects",
"Preamble",
"General Principles",
"Risk, Burdens and Benefits",
"Vulnerable Groups and Individuals",
"Scientific Req... |
NCT03608150 | 1 | BACKGROUND AND SUMMARY | 1. BACKGROUND AND SUMMARY | [] |
NCT03608150 | 1.1 | Background | 1.1. Background
Epidemiology and Clinical Characteristics Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%.1, 2 The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a co... | [
"Epidemiology and Clinical Characteristics",
"Current Treatments",
"Binocular Treatments"
] |
NCT03608150 | 1.2 | Results of Luminopia Pilot Trials | 1.2. Results of Luminopia Pilot Trials The first version of the Luminopia One therapeutic was tested in a pilot trial for feasibility and safety at Boston Children's Hospital led by Dr. David Hunter and approved by the Boston Children's Hospital Institutional Review Board. The study enrolled participants aged 7+ with a... | [] |
NCT03608150 | 1.3 | Proposed Study Design | 1.3. Proposed Study Design
Study Design Overview The proposed study is a multi-center randomized controlled clinical trial which compares mean change in amblyopic eye BCVA from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years ... | [
"Study Design Overview",
"Proposed Treatment Dosage",
"Refractive Correction Control Group",
"Proposed Primary Endpoint Duration"
] |
NCT03608150 | 1.4 | Study Endpoints | 1.4. Study Endpoints
Primary Efficacy Endpoint: • The mean change in amblyopic eye BCVA from baseline to 12 weeks of treatment with Luminopia One compared to mean change in amblyopic eye BCVA from baseline to 12 weeks with refractive correction alone.
Primary Safety Endpoint: - The mean change in fellow eye BCVA from... | [
"Primary Efficacy Endpoint:",
"Primary Safety Endpoint:"
] |
NCT03608150 | 1.5 | Synopsis of Study Design | 1.5. Synopsis of Study Design
Major Eligibility Criteria –see Section 2.2 for complete list - Age 4 to 7 years (inclusive) - Amblyopia associated with anisometropia, strabismus (≤ 5∆ at distance measured by SPCT in current refractive correction), or both - Refractive correction (if required) worn for at least 16 weeks... | [
"Major Eligibility Criteria –see Section 2.2 for complete list",
"Treatment Groups – see Section 3.1 and 3.2 for more information",
"Sample Size – see Section 6.1 for more information",
"Visit Schedule – see Section 3.4 for more information",
"Primary Endpoint Testing Procedure – see Section 3.5 for more in... |
NCT03608150 | 1.6 | Study Administration and Oversight | 1.6. Study Administration and Oversight
Medical Monitor Safety oversight will fall under the direction of a Medical Monitor with the appropriate medical and ophthalmological expertise. A Safety Management Plan will be developed prior to first participant enrollment in the trial. The Safety Management Plan will include... | [
"Medical Monitor",
"Contract Research Organization (CRO)",
"Study Summary Flow Chart (excluding Optional Visits and Calls)"
] |
NCT03608150 | 2 | PARTICIPANT ENROLLMENT | 2. PARTICIPANT ENROLLMENT | [] |
NCT03608150 | 2.1 | Informed Consent | 2.1. Informed Consent The study plans to enroll a minimum of 140 participants. A patient is considered for the study after undergoing a routine eye examination (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the... | [] |
NCT03608150 | 2.2 | Inclusion and Exclusion Criteria | 2.2. Inclusion and Exclusion Criteria | [] |
NCT03608150 | 2.2.1 | Inclusion Criteria | 2.2.1. Inclusion Criteria A participant may be enrolled in the study if all of the following criteria are met: - 1. Signed and dated informed consent form. - 2. Parent and participant understand and are willing to comply with study procedures, and will be available for the duration of the study. - 3. Age 4 to 7 years a... | [] |
NCT03608150 | 2.2.2 | Exclusion Criteria | 2.2.2. Exclusion Criteria A participant will be excluded from the study if any of the following criteria are met: - 1. Atropine treatment in the past 2 weeks. - 2. Prior amblyopia treatment (other than refractive correction) for > 12 months in total. - 3. Myopia greater than -6.00D spherical equivalent in either eye. -... | [] |
NCT03608150 | 2.3 | Testing Procedures at the Enrollment Visit | 2.3. Testing Procedures at the Enrollment Visit All examination procedures must be conducted within 7 days prior to the date of enrollment, except the cycloplegic refraction and the ocular examination, which may be performed within 7 months prior to enrollment. All examination procedures at enrollment should be perform... | [
"1. Demographics and Medical History"
] |
NCT03608150 | 2 | Stereoacuity – see Section 8.2 | 2. Stereoacuity – see Section 8.2 • Stereoacuity testing will be performed in current refractive correction by an examiner using the Titmus Fly and Randot Preschool tests. | [] |
NCT03608150 | 3 | Distance VA Testing – see Section 8.3 | 3. Distance VA Testing – see Section 8.3 • Monocular distance VA testing will be performed in current refractive correction in each eye by an examiner using the electronic ATS-HOTV visual acuity protocol. | [] |
NCT03608150 | 4 | Ocular Alignment Testing – see Section 8.4 | 4. Ocular Alignment Testing – see Section 8.4 • Ocular alignment will be assessed in current refractive correction by the simultaneous prism and cover test (SPCT) at distance. | [] |
NCT03608150 | 5 | Additional Clinical Testing | 5. Additional Clinical Testing - Ocular examination as per investigator's clinical routine (if not performed within 7 months). - Interpupillary distance see Section 8.5. | [] |
NCT03608150 | 6 | Demonstration of Ability to Use Interventions | 6. Demonstration of Ability to Use Interventions • The participant must be able to use Luminopia One and be able to wear refractive correction properly. | [] |
NCT03608150 | 7 | AE Monitoring – see Section 5.1 | 7. AE Monitoring – see Section 5.1 • The study personnel will query the participant and parent(s) to assess the occurrence of known and unknown adverse events during the screening visit.
2.4. Randomization of Enrolled Participants Participants will be randomly assigned in a 1:1 allocation to one of the following treat... | [
"2.4. Randomization of Enrolled Participants",
"2.5. Training with Study Interventions",
"2.6. Control Participants Optional Study Extension",
"3. TREATMENT GROUPS AND FOLLOW-UP",
"3.1. Therapeutic Group",
"3.2. Control Group",
"3.3. Phone Calls",
"3.4. Follow-up Visit Schedule",
"3.5. Follow-up Vis... |
NCT03608150 | 7 | REFERENCES | 7. REFERENCES - 1. Holmes JM, Clarke MP. Amblyopia. Lancet 2006;367:1343-51. - 2. Webber AL, Wood J. Amblyopia: prevalence, natural history, functional effects and treatment. Clin Exp Optom 2005;88:365-75. - 3. Agrawal R, Conner IP, Odom JV, Schwartz TL, Mendola JD. Relating binocular and monocular vision in strabismic... | [] |
NCT03608150 | 8 | APPENDICES | 8. APPENDICES | [] |
NCT03608150 | 8.1 | Appendix 1: Schedule of Events Table | 8.1. Appendix 1: Schedule of Events Table | Procedures | Visit 1:Screening | PhoneCall 1: | Visit2: | PhoneCall | Visit3: | PhoneCall | Visit4: | OptionalPhone Call | OptionalVisit 5: | |-----------------|-----------------------|------------------|-------------|---------------|-------------|---------------|------------... | [] |
NCT03608150 | 8.2 | Appendix 2: Stereoacuity Testing | 8.2. Appendix 2: Stereoacuity Testing
Titmus Fly The Titmus Fly test is to be conducted with current refractive correction. The testing distance is 40 cm. If the participant identifies the fly correctly, their stereoacuity is presumed to be 3000 seconds of arc or better. If the participant does not identify the fly co... | [
"Titmus Fly",
"Procedure",
"Randot Preschool",
"Procedure"
] |
NCT03608150 | 8.3 | Appendix 3: Distance VA Testing | 8.3. Appendix 3: Distance VA Testing Visual acuity testing is to be performed using the ATS-HOTV testing protocol with single surrounded optotypes on an electronic visual acuity (EVA) system supported by the EMMES Corporation or obtained from M&S Technologies. The Visual Acuity Protocol contains further details on the ... | [
"Screening Phase I Reinforcement Phase II",
"Screening Phase",
"Phase I",
"Reinforcement Phase",
"Phase II",
"Final Visual Acuity Score"
] |
NCT03608150 | 8.4 | Appendix 4: Ocular Alignment (Simultaneous Prism Cover Test) | 8.4. Appendix 4: Ocular Alignment (Simultaneous Prism Cover Test) The Simultaneous Prism Cover Test (SPCT) is to be conducted with current refractive correction. The SPCT is used to measure a tropia. The SPCT is performed at distance (3m) fixation using an accommodative target (never a fixation light).
Procedure - 1. ... | [
"Procedure"
] |
NCT03608150 | 8.5 | Appendix 5: Interpupillary Distance | 8.5. Appendix 5: Interpupillary Distance Interpupillary Distance (IPD) can either be measured by a ruler or by a pupilometer. The procedure for measuring IPD with a ruler is as follows:
Procedure - 1. Examiner stands at 40 cm (16 inches). - 2. Examiner closes right eye, participant fixes on examiner's left eye. - 3. E... | [
"Procedure",
"Common Difficulties and Solutions",
"Pupilometer"
] |
NCT03608150 | 8.6 | Appendix 6: Exit Questionnaire | 8.6. Appendix 6: Exit Questionnaire For parent to complete during primary endpoint visit (Visit 4) or Visit 5 (if applicable). 1.On a scale of 0 (not likely at all) to 10 (extremely likely), how likely is it that you would recommend the Luminopia therapeutic to someone else with lazy eye? 2. How likely would you be to ... | [] |
NCT03608150 | 8.7 | Appendix 7: Phone Call Questionnaire and Adverse Event Queries | 8.7. Appendix 7: Phone Call Questionnaire and Adverse Event Queries
Phone Call Questionnaire For study personnel to ask parent/guardian during phone calls. - 1. What are your general thoughts about you and/or your child's experience using Luminopia One so far? - 2. Have you and/or your child encountered any issues wit... | [
"Phone Call Questionnaire",
"Phone Call Adverse Event Query",
"In Person Adverse Event Query"
] |
NCT03608150 | 8.8 | Appendix 8: Summary of Amendment Changes | 8.8. Appendix 8: Summary of Amendment Changes
Page 1-3 - Background and Summary Current Treatments - o Paragraph beginning with "In teenagers…" since that information is irrelevant to study population age of 4-7 years.
Page 1-4 - Background and Summary Results of Luminopia One Pilot Trials - o Results from pilot tria... | [
"Page 1-3",
"Page 1-4",
"Page 1-5",
"Page 1-6",
"Page 1-7",
"Page 1-9",
"Page 2-1",
"Page 2-2",
"Page 2-4",
"Page 3-1",
"Page 3-2",
"Page 3-3",
"Page 4-1",
"Page 5-5",
"Page 6-1",
"Page 8-3",
"Page 8-5",
"Page 8-9",
"Page 8-10"
] |
NCT03608150 | 8.9 | Appendix 9: Investigators Signature | 8.9. Appendix 9: Investigators Signature Protocol Title: Luminopia One Amblyopia Vision Improvement Study Protocol Number: C-AM-2 Amendment 1 I agree to implement and conduct the study diligently and in strict compliance with the protocol, conditions of the IRB, ICH Guidelines for Good Clinical Practice (GCP) and all a... | [] |
NCT03612804 | 1.0 | Study Personnel | 1.0 Study Personnel
Principal Investigator Steven Zeliadt, PhD MPH Associate Director, Seattle/Denver Center of Innovation for Veteran-Centered and Value-Driven Care VA Puget Sound Health Care System Research Associate Professor, Department of Health Services, University of Washington
Co-Investigators Linda Nici, MD ... | [
"Principal Investigator",
"Co-Investigators",
"Collaborators:"
] |
NCT03612804 | 2.0 | Introduction | 2.0 Introduction Smoking remains the leading preventable cause of death and morbidity among Veterans. Cigarette smoking is responsible for over 440,000 deaths annually and adds \$193 billion in direct health care expenditures and productivity losses each year in the U.S. Over 50% of ever-smokers in the U.S. population ... | [] |
NCT03612804 | 3.0 | Objectives | 3.0 Objectives Objectives. We will test the value of systematically providing evidence-based tobacco treatment using a pragmatic trial of providers whose patients receive lung cancer screening in two VA Medical Centers – New York Harbor and Providence. Currently providers are encouraged to ask patients about their read... | [] |
NCT03612804 | 4.0 | Resources and Personnel | 4.0 Resources and Personnel Coordinating Center. The majority of research activities, which include primarily survey evaluation activities and medical record review, will be conducted at the Seattle/Denver HSR&D Center of Innovation (COIN) in Seattle, which will serve as the study Coordinating Center. The Coordinating ... | [
"Study Staff Table"
] |
NCT03612804 | 5.0 | Study Procedures | 5.0 Study Procedures | [] |
NCT03612804 | 5.1 | Study Design | 5.1 Study Design Study design. We are proposing a pragmatic cluster-randomized trial comparing usual lung cancer screening care to a proactive approach, which will integrate smoking cessation support into lung cancer screening. Providers will be randomized to one of two care groups. The randomization protocol will ensu... | [] |
NCT03612804 | 5.2 | Recruitment Methods | 5.2 Recruitment Methods
Number of Subjects Needed. Patients. We will assess CDW and CAPRI/JLV records for up to 15,000 patients (~10,000 to identify retrospective LCS orders, and ~5,000 to identify prospective LCS orders) who were offered lung cancer screening at NY Harbor and Providence to identify potential provider... | [
"Number of Subjects Needed.",
"Identification and Recruitment of Subjects."
] |
NCT03612804 | 5.3 | Informed Consent Procedures | 5.3 Informed Consent Procedures
Providers Waiver of written documentation of informed consent for provider participation. Providers who order lung cancer screening tests are the target for this pragmatic study. Based on recent estimates of lung cancer screening participation at VA NY Harbor and VA Providence, approxim... | [
"Providers",
"Patients"
] |
NCT03612804 | 5.4 | Inclusion/Exclusion Criteria | 5.4 Inclusion/Exclusion Criteria
Inclusion Criteria
Providers • All providers who schedule patients for an LCS at NY Harbor and Providence, RI VA systems will be eligible Patients (assessed via patient information in CAPRI/JLV) - Offered LCS by a primary care provider at NY Harbor and Providence VA systems and schedu... | [
"Inclusion Criteria",
"Providers",
"Exclusion Criteria",
"Providers",
"Patients (assessed via patient information in CAPRI/JLV)"
] |
NCT03612804 | 5.5 | Study Evaluations | 5.5 Study Evaluations Patient evaluations. The study team will query CDW twice weekly to identify scheduled LCS tests at the NY Harbor and Providence VAs. Eligibility for lung cancer screening requires the patient's provider conduct a thorough assessment of a patient's smoking history to ensure they have smoked at leas... | [] |
NCT03612804 | 5.6 | Data Analysis | 5.6 Data Analysis Sample size determination. Our target sample size of 270 respondents per arm with complete 12-month outcome information was selected to have sufficient (80%) power to detect a doubling of abstinence rates (Relative Risk = 2) using a multilevel random effects model with patients clustered by randomized... | [] |
NCT03612804 | 5.7 | Withdrawal of Subjects | 5.7 Withdrawal of Subjects Patient participants may be withdrawn without their consent if they no longer meet the study eligibility criteria (e.g. their LCS test or a short-term follow-up test identifies lung cancer or a highly suspicious finding, or if the subject becomes pregnant which is unlikely given the age eligi... | [] |
NCT03612804 | 6.0 | Reporting | 6.0 Reporting Collection of Safety Information. The study activities do not involve any invasive procedure, and it is not anticipated that serious adverse events or unanticipated problems will occur, including events that would trigger suspension of research. However, in the rare chance such an incident does occur, all... | [] |
NCT03612804 | 7.0 | Privacy and Confidentiality | 7.0 Privacy and Confidentiality PHI. Protected Health Information and personal identifying information will be obtained from existing sources (Corporate Data Warehouse, CAPRI/JLV) and from patient subjects. Names, social security numbers, birthdates, ages, appointment dates, treatment dates, date of CT screenings, tele... | [] |
NCT03612804 | 8.0 | Communication Plan | 8.0 Communication Plan Each site (NY Harbor and Providence) will submit and obtain R&D approvals. We anticipate NY Harbor and Providence R&D committees will provide guidance about requirements for annual review and/or submitting presentations/manuscripts prior to publication. The project manager at the Coordinating Cen... | [] |
NCT03612804 | 9.0 | References | 9.0 References - 1. Moyer V, Force P. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Annals of internal medicine. 2013;160(5):330–8. doi:10.7326/M13- 2771. - 2. Jackson GL, King HA, McNeil RB, et al. Evaluation of the VA Lung Cancer Screening Clinical Demonstration Project – Re... | [] |
NCT03624881 | 1.1 | Background | 1.1 Background Atrial fibrillation (AF) is the most common sustained arrhythmia in humans. It affects anywhere from 0.4% to 1% of the general population, and increases in prevalence with age, from 4 Additional ablation sites will be allowed at the discretion of the investigator but will be limited to certain parameters... | [] |
NCT03624881 | 1.2 | Rationale | 1.2 Rationale The theoretical benefits of catheters with CF sensing technology include feedback to the user of adequate degree of tissue contact to prevent inappropriate RF power application. The data from carefully controled studies have shown when investigators stay within their pre-selected contact force range > 80%... | [] |
NCT03624881 | 1.3 | Risk Analysis | 1.3 Risk Analysis RF catheter ablation has been used for over 15 years, and the risks and complications are well understood. A summary of risks associated with catheter ablation, including analysis of and plans to minimize these risks is provided below: | [] |
NCT03624881 | 1.3.1 | Description and Analysis of Risks | 1.3.1 Description and Analysis of Risks Risks associated with catheter ablation The risk of pulmonary adverse events (e.g. PV stenosis, thrombus and hypertension) associated with an AF ablation procedure targeting the pulmonary veinsis considered small (51 Additionally, in the SMART-SF study using a new investigational... | [] |
NCT03624881 | 1.3.2 | Minimization of Risks | 1.3.2 Minimization of Risks The risks associated with performing RF catheter ablation using an ablation catheter with CF sensing technology, such as the THERMOCOOL SMARTTOUCH® SF and THERMOCOOL SMARTTOUCH® catheters, are similar to conventional irrigated catheters that do not include this technology. Similarly, the Sur... | [] |
NCT03624881 | 1.3.3 | Precautions | 1.3.3 Precautions Invasive electrophysiological evaluation and catheter ablation may impart some degree of risk to the subject. The risk of serious complications is generally related to the severity of cardiac disease. The degree of risk of the electrophysiological and catheter ablation procedures versus the potential ... | [] |
NCT03624881 | 1.4 | Device Description | 1.4 Device Description The Biosense Webster THERMOCOOL SMARTTOUCH® family of catheters are steerable, multi-electrode, luminal catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit RF current to the catheter tip dome electrode for ablation purposes. The cathet... | [] |
NCT03624881 | 1.4.1 | THERMOCOOL SMARTTOUCH® SF catheter | 1.4.1 THERMOCOOL SMARTTOUCH® SF catheter The catheter has a high-torque shaft, with either a uni-directional or bi-directional braided deflectable tip section, containing an array of ring electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the cathete... | [] |
NCT03624881 | 1.4.1.1 | Bi-directional Catheter Description (D-1348-XX-S) | 1.4.1.1 Bi-directional Catheter Description (D-1348-XX-S) The catheter has a high-torque shaft with a bi-directional deflectable tip section containing an array of electrodes which includes a 3.5 mm tip dome. All of the electrodes may be used for recording and stimulation purposes. The tip electrode serves to deliver R... | [] |
NCT03624881 | 1.4.1.2 | Uni-directional Catheter Description (D-1347-XX-S) | 1.4.1.2 Uni-directional Catheter Description (D-1347-XX-S) The catheter has a high-torque shaft with a Uni-Directional deflectable tip section containing an array of electrodes which includes a 3.5 mm tip dome. All of the electrodes may be used for recording and stimulation purposes. The tip electrode serves to deliver... | [] |
NCT03624881 | 1.4.2 | THERMOCOOL SMARTTOUCH® catheter | 1.4.2 THERMOCOOL SMARTTOUCH® catheter  | [] |
NCT03624881 | 1.4.2.1 | Bi-directional Catheter Description (D-1327-0X-S) | 1.4.2.1 Bi-directional Catheter Description (D-1327-0X-S) The bi-directional catheter has a high-torque shaft with a bi-directional deflectable tip section containing an array of electrodes, which includes a 3.5 mm tip dome. All of the electrodes may be used for recording and stimulation purposes. The tip electrode ser... | [] |
NCT03624881 | 1.4.2.2 | Uni-directional Catheter Description (D-1336-0X-S) | 1.4.2.2 Uni-directional Catheter Description (D-1336-0X-S) The unidirectional catheter has a high-torque shaft with a uni-directional deflectable tip section containing an array of electrodes, which includes a 3.5 mm tip dome. All of the electrodes may be used for recording and stimulation purposes. The tip electrode s... | [] |
NCT03624881 | 1.5 | Approved Catheters | 1.5 Approved Catheters The THERMOCOOL SMARTTOUCH® Diagnostic /Ablation Deflectable Tip Catheters with Contact Force Sensing Capability (D-1327-0X-S and D-1336-0X-S) and the THERMOCOOL SMARTTOUCH® SF Diagnostic /Ablation Deflectable Tip Catheters with Contact Force Sensing Capability (D-1347-XX-S and D-1348-XX-S) are th... | [
"Instructions for Use (IFU)"
] |
NCT03624881 | 1.6 | Supply of Approved Catheter | 1.6 Supply of Approved Catheter The THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters have been approved for the treatment of drug refractory PAF. Catheters used in this study can be taken from commercial stock. | [] |
NCT03624881 | 1.7 | VISITAG SURPOINT™ Module (Tag Index) | 1.7 VISITAG SURPOINT™ Module (Tag Index) The VISITAG SURPOINT™ module is a lesion quality marker that utilizes contact force, time, and power to calculates Tag Index values that are displayed on the CARTO 3 system screen. The formula (a weighted Force-Power-Time Integral) was developed as a marker of ablation outcome a... | [] |
NCT03624881 | 1.8 | VISITAG SURPOINT™ EPU Description | 1.8 VISITAG SURPOINT™ EPU Description The EPU is an external hardware designed to perform Tag Index calculations. The EPU receives ablation data (power, contact force, and duration) from the CARTO® 3 System, computes the Tag Index values, and then returns the computed results for display in the CARTO® 3 System. A pictu... | [] |
NCT03624881 | 1.8.1 | VISITAG SURPOINT™ EPU indication for Use | 1.8.1 VISITAG SURPOINT™ EPU indication for Use The VISITAG SURPOINT™ EPU is intended to perform Tag Index calculations combining parameters of power, contact force, and duration during electrophysiology procedures. The EPU is intended for use with the CARTO® 3 System (software version 6.0.60 or higher) with the CARTO V... | [] |
NCT03624881 | 1.8.2 | Principles of Operation | 1.8.2 Principles of Operation The EPU is an external processing unit connected to the CARTO® 3 System Workstation through a USB cable. The EPU receives ablation data from the CARTO® 3 System Workstation, namely data streams of ablation power, contact force, and duration. The EPU operates automatically whenever the CART... | [
"STUDY OBJECTIVE",
"STUDY DESIGN"
] |
NCT03624881 | 3.1 | Subject Selection | 3.1 Subject Selection | [] |
NCT03624881 | 3.1.1 | Inclusion Criteria | 3.1.1 Inclusion Criteria Candidates for this study must meet ALL of the following criteria: 1. Symptomatic paroxysmal AF who had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holte... | [] |
NCT03624881 | 3.1.2 | Exclusion Criteria | 3.1.2 Exclusion Criteria Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply: - 1. Previous surgical or catheter ablation for atrial fibrillation - 2. Previous cardiac surgery (including CABG) within the past 6 months (180 days) - 3. Valvular cardiac surgical/percutaneous ... | [] |
NCT03624881 | 3.2 | Subject Disposition | 3.2 Subject Disposition - Enrolled Subjects: subjects who sign the informed consent. - Excluded Subjects: subjects who do not have the STSF/ST catheter inserted or have the STSF/ST catheter inserted but do not undergo ablation with VISITAG SURPOINT™ Module. Subjects who have the STSF/ST catheter inserted but do not und... | [] |
NCT03624881 | 3.3 | Subject Withdrawal/Early Termination | 3.3 Subject Withdrawal/Early Termination Subjects may withdraw from the clinical investigation at any time. The decision for the subject to withdraw informed consent must be made independently of influence by the investigator or site personnel. The subject's decision will be documented in the source and eCRF. The inves... | [] |
NCT03624881 | 3.4 | Subjects Lost to Follow up | 3.4 Subjects Lost to Follow up Subjects should be encouraged to return for protocol required, clinic visits for evaluation during the study follow-up period. If a subject is unable to return for an office or clinic visit or unable to be contacted by telephone, 3 separate telephone calls should be made to obtain subject... | [
"STUDY ENDPOINTS"
] |
NCT03624881 | 4.1 | Primary Endpoints | 4.1 Primary Endpoints | [] |
NCT03624881 | 4.1.1 | Primary Effectiveness Endpoint | 4.1.1 Primary Effectiveness Endpoint The primary effectiveness endpoint is defined as the freedom from documented (Symptomatic and asymptomatic) atrial fibrillation, atrial flutter and atrial tachycardia (AF/AFL/AT) (hereinafter collectively referred to as "atrial tachyarrhythmias") recurrence (episodes ≥ 30 secs on TT... | [] |
NCT03624881 | 4.1.2 | Primary Safety Endpoint | 4.1.2 Primary Safety Endpoint The primary safety endpoint is the incidence of any primary adverse event occurring within 7 days following an AF ablation procedure (including the initial and repeat procedures) using the STSF/ST catheter with the EPU per protocol, except atrio-esophageal fistula and PV stenosis, which ma... | [] |
NCT03624881 | 4.2 | Secondary Endpoints | 4.2 Secondary Endpoints | [] |
NCT03624881 | 4.2.1 | Secondary Effectiveness Endpoints | 4.2.1 Secondary Effectiveness Endpoints - Acute Procedural Success - o % of subjects with ipsilateral PVI (entrance block) at the end of the procedure - o % of subjects with ipsilateral PV isolation (entrance block) after first encirclement (evaluated prior to the 30-minute waiting period and adenosine challenge) - o %... | [
"• 12-Month Single Procedure Success"
] |
NCT03624881 | 4.2.2 | Secondary Safety Endpoints | 4.2.2 Secondary Safety Endpoints - 12-Month PAE Rate: Cumulative incidence of primary adverse events occurring within seven (7) days following an AF ablation procedure using study catheters with EPU and any late onset atrio-esophageal fistula or PV stenosis through 12 months - Incidence of Unanticipated Adverse Device ... | [] |
NCT03624881 | 4.3 | Additional Endpoints | 4.3 Additional Endpoints No formal statistical hypothesis and inferential statistics will be formulated and performed for the additional endpoints. - Procedural Data: - o Total procedure time, PVI time, RF application time, mapping time and RF application time per lesion - o Total Fluoroscopy Time/dose - o Fluid delive... | [] |
NCT03624881 | 4.4 | Health Economic Data | 4.4 Health Economic Data The cost and frequency of health care utilization during hospitalization for the study index ablation procedure, as well as any additional hospitalizations during the study period will be collected. Because this data does not support the safety and effectiveness of the STSF/ST Catheter and the ... | [
"TREATMENT DESCRIPTION"
] |
NCT03624881 | 5.1 | Patient Screening | 5.1 Patient Screening All patients considered for RF ablation procedure for drug refractory recurrent symptomatic PAF should be evaluated by the investigator or designated member of the research team for study eligibility per the protocol inclusion and exclusion criteria. Subjects are enrolled upon signing the informed... | [] |
NCT03624881 | 5.2 | Informed Consent | 5.2 Informed Consent Signing of an approved Informed Consent form (ICF) or Patient Information/Informed Consent form (PI/ICF) by the study candidate documents the patient's acceptance and enrollment in the study. Prior to signing, the investigator or authorized member of the research team should discuss the background,... | [] |
NCT03624881 | 5.3 | Pre-Procedure Assessments | 5.3 Pre-Procedure Assessments Pre-procedure assessments should be performed within 30 days prior to the index AF ablation procedure unless otherwise noted. Some assessments (listed below) have a shorter window prior to the AF ablation procedure. - Transthoracic Echocardiogram (TTE) Imaging to determine the atrial size ... | [] |
NCT03624881 | 5.4 | General AF Procedure Guidelines | 5.4 General AF Procedure Guidelines The AF ablation procedures for this study should follow the sequence below: - Diagnostic catheter placement - Electrophysiology study (discretion of investigator) - Transseptal puncture - Cardioversion if subject is in AF (discretion of investigator) - A left atrial anatomical map is... | [] |
NCT03624881 | 5.5 | Esophageal Monitoring | 5.5 Esophageal Monitoring REQUIRED: An appropriate strategy to minimize risk of esophageal injury MUST be used to ensure the physician has accurate information about the location of the esophagus relative to intended sites of ablation. The method used to localize the esophagus will be collected in the CRFs. At least on... | [] |
NCT03624881 | 5.6 | Recommended RF Power: | 5.6 Recommended RF Power: - A RF power range of 15-45 Watts (W) is recommended for atrial ablation.7-10 - Do not rely on the catheter tip temperature response to guide ablation. If the temperature increases rapidly, stop RF application immediately. - At anatomical locations other than the LA posterior wall or CS: - o M... | [] |
NCT03624881 | 5.7 | Contact Force (CF) Settings | 5.7 Contact Force (CF) Settings Operators should select individualized CF target ranges based on their case experience and the prior results from the THERMOCOOL SMARTTOUCH® SF catheter IDE trial. 24 - Contact Force settings: - o Contact Force Target range: 5-25 gram (recommended) - o Minimum CF of 3-5 grams - Risk of c... | [] |
NCT03624881 | 5.8 | VISITAG™ Settings | 5.8 VISITAG™ Settings • Stability Settings: o Range: 2-3 mm o Time: 3-5 seconds - Filter (FOT) Settings: - o If an FOT filter is desired, the percentage of time of the chosen gram force should be 25%. - Tag size 3mm - Maximum Inter tag distance 6mm | [] |
NCT03624881 | 5.9 | VISITAG SURPOINT™ Tag Index Targets | 5.9 VISITAG SURPOINT™ Tag Index Targets VISITAG SURPOINT™ Module Tag Index target values for specified anatomical locations: - Anterior, Ridge, Roof segments target value: 550 - Posterior and inferior segments target value: 380 NOTE 1: All Tag Index target values, especially the posterior wall, are in the absence of sa... | [] |
NCT03624881 | 5 | 10Ablation Procedure | 5.10Ablation Procedure The ablation procedure includes PVI, ablation of non-PV triggers and substrate modification. Study procedure requirements are outlined below: - PVI of all PV's are required (acute success) - Linear ablation lines are only required to treat documented macro-reentry atrial tachycardia's and limited... | [] |
NCT03624881 | 5 | 11Post Ablation | 5.11Post Ablation - Verification of entrance block is required for all PVs. - o A 30-minute waiting period is REQUIRED from the last RF application at a PV before verification may be confirmed. If reconduction is noted, additional RF applications should be applied and a second 30-minute waiting period will be required ... | [] |
NCT03624881 | 5 | 12Post Procedure Assessments | 5.12Post Procedure Assessments - Before hospital discharge: - o Occurrence of arrhythmias, if any - o Electrocardiogram (12-Lead ECG) - o Transthoracic Echocardiogram (TTE), if necessary. Subjects who develop symptoms suggestive of pericardial effusion and/or pericarditis should undergo a transthoracic echocardiogram (... | [
"• Follow-up measurements at 1-Month (+/-7days):"
] |
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