protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03624881 | 5 | 13Standard Tests and Procedures | 5.13Standard Tests and Procedures The required schedule for subject treatments and evaluations is summarized in Table 5-1. Table 5-1 Schedule of Treatments and Evaluations | | | Pre-Procedure | | | PhoneCall | Follow-Up Visits | | | | | |-------------------------------------|----------------|-------------------------|-... | [] |
NCT03624881 | 5.14 | Study Medications | 5.14 Study Medications The following medications are recommended/required (as indicated) for subjects undergoing a Study procedure ablation for AF. | [] |
NCT03624881 | 5.14 | 1Anticoagulation Medications | 5.14.1Anticoagulation Medications
• Medication Prior to AF Ablation Procedure o Subject should be placed on systemic anticoagulation therapy for at least 3 weeks prior to the AF ablation procedure.
• Medication During AF Ablation Procedure - o Heparin: to achieve an activated clotting time (ACT) of ≥ 325 seconds duri... | [
"• Medication Prior to AF Ablation Procedure",
"• Medication During AF Ablation Procedure",
"• Medication Following AF Ablation Procedure"
] |
NCT03624881 | 5 | 15Antiarrhythmic Drug (AAD) Management | 5.15Antiarrhythmic Drug (AAD) Management | [] |
NCT03624881 | 5.15.1 | Definitions | 5.15.1 Definitions • Antiarrhythmic drugs (AADs) - o The study protocol will classify and analyze the following: - o Class I drugs (e.g., flecainide, propafenone, disopyramide, etc.) - o Class III drugs (e.g., amiodarone, dronedarone, dofetilide, etc.)
• Previously Failed AAD Any AAD that a subject has ever taken for ... | [
"• Previously Failed AAD",
"• New AAD"
] |
NCT03624881 | 5 | 16Heart Rhythm Monitoring | 5.16Heart Rhythm Monitoring ECG, Transtelephonic monitors (TTM) and 24 Hour Holter Monitoring will be used to monitor the subjects' heart rhythm post-treatment.
Electrocardiogram (12-lead ECG): ECG device will be provided to each site. Sites will be instructed to record and transmit for every subject per the schedule ... | [
"Electrocardiogram (12-lead ECG):",
"Transtelephonic Monitors (TTM):",
"Holter Monitoring:"
] |
NCT03624881 | 5.17 | Study Equipment | 5.17 Study Equipment | [] |
NCT03624881 | 5.17.1 | Required Catheters and Equipment | 5.17.1 Required Catheters and Equipment The following devices are required for the AF ablation procedure during this study: Table 5-2 Required Study Equipment | | SURPOINT COAClinical Study Protocol (BWI201706)Table 5-2 Required Study Equipment | |------------------------------------------------------------------------... | [] |
NCT03624881 | 5.17.2 | Recommendation for Irrigation Pump Setting and RF Power Delivery | 5.17.2 Recommendation for Irrigation Pump Setting and RF Power Delivery The Irrigation Pump will deliver a continuous infusion of 2 ml/min of room temperature heparinized saline (1 u heparin/l ml saline) when not delivering RF current. Operators should increase the irrigation to high flow rate starting up to 5 seconds ... | [] |
NCT03624881 | 5.17.3 | Investigator Training | 5.17.3 Investigator Training
SMARTTOUCH SF Catheter Training: Investigators selected to participate in the study will be skilled in intracardiac mapping and AF ablation with THERMOCOOL SMARTTOUCH® and THERMOCOOL SMARTTOUCH® SF catheters (>20 cases). They will provide 5 Retrospective PAF cases with segmented VISITAGTM ... | [
"SMARTTOUCH SF Catheter Training:",
"VISITAG SURPOINTTM Module:",
"FIGURE 5.17.3A: An example of retrospective analysis:"
] |
NCT03624881 | 5.18 | Repeat AF Ablation Procedures | 5.18 Repeat AF Ablation Procedures Repeat AF ablations(s) may be performed at the discretion of the physician. The follow-up schedule (Medication Adjustment and Therapy Consolidation periods and exam intervals) will continue based on the initial AF ablation procedure performed, regardless of repeat ablations. The follo... | [] |
NCT03624881 | 5.19 | Core Laboratory | 5.19 Core Laboratory A core laboratory will be used for objective evaluation of the TTMs and 24 Hr Holter for the evaluation of recurrence of atrial tachyarrhythmias. Evaluations will be reviewed by a physician. AF episodes will be evaluated per the definition included in this protocol. Biosense Webster, Inc Version 4.... | [
"ADVERSE EVENTS"
] |
NCT03624881 | 6.1 | Adverse Event Recording | 6.1 Adverse Event Recording An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure. Adverse events will be collected from si... | [] |
NCT03624881 | 6.2 | Classification | 6.2 Classification Any of the following events are to be reported to the sponsor immediately. The Sponsor may request additional information after the initial notification. | [] |
NCT03624881 | 6.2.1 | Primary Adverse Event | 6.2.1 Primary Adverse Event A Primary AE is one of the following events occurring within seven (7) days following an AF ablation procedure with the STSF/ST catheter and VISITAG SURPOINT™ module with EPU, except atrio-esophageal fistula and PV stenosis, which may also be considered as primary adverse events if occurring... | [
"All reported Primary AEs will be monitored until they are adequately resolved or explained."
] |
NCT03624881 | 6.3 | Serious AEs | 6.3 Serious AEs A serious adverse event (SAE) is any event that meets one or more of the following criteria: - Lead to a death - Lead to a serious deterioration in the health of a subject that: - o Resulted in a life-threatening illness or injury - o Resulted in a permanent impairment of a body structure or a body func... | [] |
NCT03624881 | 6.4 | Non-Serious AEs (NSAEs) | 6.4 Non-Serious AEs (NSAEs) A non-serious AE is any event that results in minimal transient impairment of a body function or damage to a body structure, and does not require any intervention listed under the criteria for "Serious Adverse Event." Nonserious adverse events require routine reporting via EDC. | [] |
NCT03624881 | 6.5 | Anticipated AEs | 6.5 Anticipated AEs An anticipated AE is one that has been reported in previous studies of RF ablation and can be anticipated in this current study as per the risk analysis. Table 6-2 provides a comprehensive list of anticipated AEs. Table 6-2 Anticipated Adverse Events | | Auticipated Adverse Events | | |------------|... | [] |
NCT03624881 | 6.6 | Unanticipated Serious Adverse Device Effect | 6.6 Unanticipated Serious Adverse Device Effect A (serious) adverse device effect (ADE/SADE) is any (serious) adverse effect on subjects' health, safety, rights, welfare, and life-threatening problems including death, which is caused by, or associated with the study device. Accordingly, relationship to device or study ... | [] |
NCT03624881 | 6.7 | Clinical Investigation Device Failure/Malfunction/Deficiency | 6.7 Clinical Investigation Device Failure/Malfunction/Deficiency A device has failed if it does not perform according to the instructions for use or fails to meet the expectations of the device and/or investigator (i.e., related to appearance of the device, performance, durability, safety, effectiveness, quality, relia... | [] |
NCT03624881 | 6.8 | Reporting Requirements | 6.8 Reporting Requirements All serious AEs, UADE/SADE/USADE, and Study device failure/malfunction/deficiency, whether or not they are related to the device or procedure, must be reported by eCRF to the Sponsor (Biosense Webster Clinical Operations). Investigators/sites are expected to report any Primary AEs, Serious AE... | [] |
NCT03624881 | 6.9 | Intensity or Severity | 6.9 Intensity or Severity Intensity (or severity) of AEs is defined as follows: Table 6-3 Intensity or Severity Definitions | Mild | Events that result in minimal transient impairment of a body function ordamage to a body structure, and/or dos not require intervention other thanmonitoring. | |----------|---------------... | [] |
NCT03624881 | 6.10 | Outcome | 6.10 Outcome AE outcomes are assessed according to the following classifications: Table 6-4 Adverse Event Outcome Classifications | outcomes are assessed according to the following classifications: | | | | | | | |-------------------------------------------------------------------|---------------------------------------... | [] |
NCT03624881 | 6.11 | Causality | 6.11 Causality Cause of AEs is defined as follows: Table 6-5 Adverse Event Causality Classifications | Device Relationship | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03624881 | 6.12 | Documentation | 6.12 Documentation All AEs must be documented on the appropriate eCRF. All AEs must be monitored until they are adequately resolved or stabilized, with follow-up reports submitted to the Sponsor or designee as soon as new information becomes available. Additional documentation may be requested by the Sponsor or designe... | [] |
NCT03624881 | 6.13 | Clinical Events Committee (CEC) | 6.13 Clinical Events Committee (CEC) Primary Adverse Events and Serious Adverse Events of cardiac origin occurring throughout the study period (1-year) will be reviewed by Biosense Webster clinical staff with Medical Safety Officer or designee, and submitted to the independent Clinical Events Committee (CEC) for review... | [
"STATISTICAL ANALYSIS METHODS"
] |
NCT03624881 | 7.1 | Study Design | 7.1 Study Design The SURPOINT COA study is a prospective, multicenter, non-randomized clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF and ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A maximum of 330 subjects will be enroll... | [] |
NCT03624881 | 7.2 | Treatment Assignment | 7.2 Treatment Assignment This is a single-arm study. The only treatment assigned is the THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheters using VISITAG SURPOINT™ Module with External Processing Unit (EPU). | [] |
NCT03624881 | 7.3 | Randomization and Blinding Procedures | 7.3 Randomization and Blinding Procedures This study is a non-randomized single-arm study. An independent group will perform the Bayesian interim analyses. The sponsor is not blinded to individual or aggregated data. | [] |
NCT03624881 | 7.4 | Interval Windows | 7.4 Interval Windows The required schedule for subject treatments and evaluations is summarized in Table 5-1 of the study protocol. | [] |
NCT03624881 | 7.5 | Primary and Secondary Endpoint(s) and Associated Hypotheses | 7.5 Primary and Secondary Endpoint(s) and Associated Hypotheses | [] |
NCT03624881 | 7.5.1 | Primary Endpoints and Associated Hypotheses | 7.5.1 Primary Endpoints and Associated Hypotheses | [] |
NCT03624881 | 7.5.1.1 | Primary Effectiveness Endpoint | 7.5.1.1 Primary Effectiveness Endpoint The primary effectiveness endpoint of this study is the effectiveness success rate at Month 12, defined as the proportion of subjects who are freedom from documented (symptomatic and asymptomatic) atrial fibrillation, atrial flutter and atrial tachycardia (AF/AFL/AT) (hereinafter ... | [] |
NCT03624881 | 7.5.1.2 | Primary Safety Endpoint | 7.5.1.2 Primary Safety Endpoint The primary safety endpoint is the proportion of subjects with any primary adverse event (PAE) occurring within 7 days following the AF ablation procedure (including the initial and repeat procedures) using the STSF catheter with EPU, except atrio-esophageal fistula and PV stenosis, whic... | [] |
NCT03624881 | 7.5.2 | Secondary Endpoints | 7.5.2 Secondary Endpoints No formal statistical hypothesis and inferential statistics will be formulated and performed for the secondary effectiveness and safety endpoints. | [] |
NCT03624881 | 7.5.2.1 | Secondary Effectiveness Endpoints | 7.5.2.1 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 PVI (entrance block) after first encirclement (evaluated prior to the 30-minute waiting period and adenosine challenge) - o % of tou... | [] |
NCT03624881 | 7.5.2.2 | Secondary Safety Endpoints | 7.5.2.2 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 Devic... | [] |
NCT03624881 | 7.5.3 | Additional Endpoints | 7.5.3 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 - o Fluid delivere... | [
"• Procedural Data:"
] |
NCT03624881 | 7.5.4 | Health Economic Data | 7.5.4 Health Economic Data The primary health economic data will include the cost and frequency of hospitalization for the study index ablation procedure, as well as any additional hospitalizations during the study period. The health care utilization during hospitalizations will be assessed by utilizing all data availa... | [] |
NCT03624881 | 7.6 | Level of Significance | 7.6 Level of Significance The type I error for the interim and final analyses of the primary endpoints is controlled at onesided 5%. Please refer to Appendix C for the operating characteristics of the Bayesian adaptive design including the type-I error simulation results. | [] |
NCT03624881 | 7.7 | Analysis Sets | 7.7 Analysis Sets For the analysis of study endpoints, the analysis populations defined in the following will be used: - Safety Population: The SP will consist of all enrolled subjects who have undergone insertion of the STSF/ST catheters and use of the VISITAG SURPOINT™ Module with EPU. The safety population (SP) will... | [] |
NCT03624881 | 7.8 | Sample Size Justification | 7.8 Sample Size Justification The final analyses for primary safety and effectiveness endpoints will apply Bayesian methods and use a beta-binomial model. The power calculations for the Bayesian adaptive design are presented in the simulation report Appendix C Table 6 (probability of success). Under the assumption of 6... | [] |
NCT03624881 | 7.9 | Statistical Analysis Methods | 7.9 Statistical Analysis Methods | [] |
NCT03624881 | 7.9.1 | General Conventions | 7.9.1 General Conventions In general, descriptive statistics will summarize all primary, secondary, and additional endpoints as appropriate. For continuous variables, number of subjects/events, mean, standard deviation, median, 25% percentile, 75% percentile, minimum, and maximum will be provided. For categorical varia... | [] |
NCT03624881 | 7.9.2 | Subject Disposition | 7.9.2 Subject Disposition Disposition of the study subjects are defined as the following. - Enrolled Subjects: subjects who sign the informed consent. - Excluded Subjects: subjects who do not have the STSF/ST catheters inserted or have the STSF/ST catheters inserted but do not undergo ablation with VISITAG SURPOINT™ Mo... | [] |
NCT03624881 | 7.9.3 | Demography and Baseline Characteristics | 7.9.3 Demography and Baseline Characteristics Subject demographics, medical history, AAD medical history and other baseline data will be summarized descriptively for all enrolled subjects as well as the safety and PP populations. | [] |
NCT03624881 | 7.9.4 | Analysis of Primary Endpoints | 7.9.4 Analysis of Primary Endpoints The primary effectiveness endpoint is the proportion of patients that are free from primary effectiveness failure at Month 12. The failure modes are defined in the section 7.5.1.1. The effectiveness success rate at Month 12 will be compared against the performance goal of 50%. The pr... | [] |
NCT03624881 | 7.9.4.1 | Final Analysis | 7.9.4.1 Final Analysis The primary goal of the trial is to demonstrate effectiveness and safety. For the trial to be successful, both endpoints must be statistically significant relative to their respective PG goals. The effectiveness endpoint will be assessed by testing the hypotheses: $$H0$$ : $Pr(p > 0.5|x, n) \le 0... | [] |
NCT03624881 | 7.9.4.2 | Interim Analysis | 7.9.4.2 Interim Analysis Two interim analyses are planned. The first will occur once all subjects who are treated using STSF catheter with EPU have completed their 3 months follow-up. The second interim will occur when all subjects who are treated using STSF catheter with EPU have completed their 6 months follow-up. Th... | [] |
NCT03624881 | 7.9.4.3 | Handling of Missing Data | 7.9.4.3 Handling of Missing Data At the time of each interim analysis, some subjects will not have completed the full 12-month evaluation period. For example, recently enrolled subjects who are currently failure-free but have only been observed for a portion of the observation period will have "censored" final outcomes... | [] |
NCT03624881 | 7.9.4.4 | Sensitivity Analyses | 7.9.4.4 Sensitivity Analyses Provided in detail in the SAP. | [] |
NCT03624881 | 7.9.5 | Additional Analysis for Primary Effectiveness Endpoint | 7.9.5 Additional Analysis for Primary Effectiveness Endpoint Provided in detail in the SAP. | [] |
NCT03624881 | 7.9.6 | Analysis of Secondary Endpoints | 7.9.6 Analysis of Secondary Endpoints Provided in detail in the SAP. | [] |
NCT03624881 | 7.9.7 | Analysis of Additional Endpoints | 7.9.7 Analysis of Additional Endpoints Provided in detail in the SAP. | [] |
NCT03624881 | 7.9.8 | Analysis of Health Economic Data | 7.9.8 Analysis of Health Economic Data Provided in detail in the SAP. | [] |
NCT03624881 | 7.10 | Data Monitoring Committee | 7.10 Data Monitoring Committee No Data Monitoring Committee will be formed for this study.
ADMINISTRATIVE RESPONSIBILITIES | [
"ADMINISTRATIVE RESPONSIBILITIES"
] |
NCT03624881 | 8.1 | Ethics Review | 8.1 Ethics Review Study materials including informed consent must be reviewed and approved by an appropriately-constituted IRB/IEC/REB before enrollment of subjects. Biosense Webster and the IRB must approve in writing any changes to the protocol. Proof of IRB/IEC/REB review and approval must be obtained prior to subje... | [] |
NCT03624881 | 8.2 | Patient Informed Consent | 8.2 Patient Informed Consent Biosense Webster and the reviewing IRB/IEC/REB must approve any modifications to the ICF or PI/ICF. The ICF may be translated as appropriate. Certification of accurate translation will be required. Informed consent is mandatory and must be obtained from all subjects prior to their participa... | [] |
NCT03624881 | 8.3 | Confidentiality | 8.3 Confidentiality All information and data sent to Biosense Webster concerning subjects or their participation in this study will be considered confidential. Only authorized Biosense Webster personnel or representatives, or representatives of Health Authorities (HA) or Regulatory Authorities (RA) acting in their offi... | [] |
NCT03624881 | 8.4 | Data Management | 8.4 Data Management | [] |
NCT03624881 | 8.4.1 | Case Report Forms (CRFs) | 8.4.1 Case Report Forms (CRFs) Electronic CRFs will be used to collect all subject data during the study. | [] |
NCT03624881 | 8.4.2 | Data Reporting | 8.4.2 Data Reporting The investigator, or a designated individual, is responsible for recording data from the trial on the eCRFs supplied by Biosense Webster. The investigator or a delegated individual is required to electronically sign eCRFs on the appropriate pages to verify that he/she has reviewed and attests to th... | [] |
NCT03624881 | 8.4.3 | Data Review | 8.4.3 Data Review Biosense Webster will track the amount of missing data and contact sites as appropriate to instruct them on steps to minimize missing data and remain compliant with protocol required assessments. Missing or unclear data points will be queried as necessary throughout the trial. Biosense Webster may req... | [] |
NCT03624881 | 8.5 | Records and Reports | 8.5 Records and Reports | [] |
NCT03624881 | 8.5.1 | Records | 8.5.1 Records Records to be maintained by the investigator may include but not limited to: - Study protocol and all amendments with signature pages - Signed clinical study agreement and Statement of Investigator - IRB/IEC/REB approval letter, including approved ICF document - Evidence of IRB/IEC/REB compliance - Other ... | [] |
NCT03624881 | 8.5.2 | Record Retention | 8.5.2 Record Retention Records and reports of the study will remain on file at sites for a minimum of two (2) years after its completion/termination. Records for U.S. sites must be maintained in accordance with 21 CFR 812.140 [d], and for OUS sites, according to local requirements. If the principal investigator plans t... | [] |
NCT03624881 | 8.5.3 | Procedural Data | 8.5.3 Procedural Data It is the responsibility of the investigator to provide timely completion of CRFs to the sponsor. | [] |
NCT03624881 | 8.5.4 | Investigator's Final Report | 8.5.4 Investigator's Final Report Upon completion or termination of the Biosense Webster study, the principal investigator must submit a final written report to the approving Investigational Review Board/Ethics Committee (as required by the IRB/IEC/REB) and provide a copy to Biosense Webster. The report should contain ... | [] |
NCT03624881 | 8.5.5 | Interim Post-Approval Study Status Report | 8.5.5 Interim Post-Approval Study Status Report An Interim Post-Approval Study Status Report will be provided to the FDA on the status of the post-approval study every 6 months for the first 2 years after the PMA approval and annually, thereafter. The interim status report will include the following data to be posted b... | [] |
NCT03624881 | 8.6 | Labeling | 8.6 Labeling THERMOCOOL SMARTTOUCH® and THERMOCOOL SMARTTOUCH® SF Diagnostic/Ablation Deflectable Tip Catheters with Contact Force Sensing Capability Instructions for Use is included in each product package. | [] |
NCT03624881 | 8.7 | Deviations from Protocol and Good Clinical Practice | 8.7 Deviations from Protocol and Good Clinical Practice The investigator should not deviate from the protocol except in medical emergencies. In emergencies, prior approval for a protocol deviation will not be required, but the Biosense Webster clinical operations personnel should be notified as soon as possible. IRB/RE... | [
"STUDY MANAGEMENT"
] |
NCT03624881 | 9.1 | Study Timelines | 9.1 Study Timelines Study Duration: The study is expected to last Approximately 2.5 years (~1.0 years for enrollment; 12 months of follow-up for primary endpoint). | Expected date of study initiation | 3Q 2018 | |--------------------------------------------------------------|--------------------------------------------... | [] |
NCT03624881 | 9.2 | Investigator Responsibilities | 9.2 Investigator Responsibilities The Principal Investigator is responsible for supervision of all study activities and is ultimately responsible for overall compliance with protocol, GCP, local and regional regulations, and IRB/REB requirements. Many study activities may be formally delegated to support staff, but the... | [] |
NCT03624881 | 9.3 | Sponsor Responsibilities | 9.3 Sponsor Responsibilities The Sponsor (Biosense Webster) will be responsible for the following: - Preparing of study documents including but not limited to the protocol, eCRFs and template informed consent, if no local template is preferred - Completing pre-study site assessments and approvals - Obtaining approval f... | [] |
NCT03624881 | 9.4 | Training | 9.4 Training | [] |
NCT03624881 | 9.4.1 | Research Team | 9.4.1 Research Team The training of appropriate clinical site personnel will be the responsibility of the Sponsor or the Sponsor's representative. In some cases, training may be performed by an existing site staff member who has already been trained by the Sponsor (such as assigning a new Clinical Research Coordinator ... | [] |
NCT03624881 | 9.5 | Sponsor Contact Information | 9.5 Sponsor Contact Information  | [] |
NCT03624881 | 9.6 | Initiation of the Investigation | 9.6 Initiation of the Investigation Potential research sites will undergo prestudy evaluations to ensure their qualification for supporting the study. Selected sites will be provided with appropriate study-specific training prior to commencement of activities. | [] |
NCT03624881 | 9.7 | Monitoring the Study | 9.7 Monitoring the Study Each site will undergo periodic monitoring of the study, which involves a visit from a trained Sponsor representative. Monitoring visits may include, but will not be limited to, the following: - Verification of accuracy of study logs such as the Delegation of Responsibility, etc. - Verification... | [] |
NCT03624881 | 9.8 | Termination of the Study | 9.8 Termination of the Study The study may be suspended or terminated early at the discretion of the Sponsor, for reasons such as incidence of unanticipated serious adverse device effects that may pose a risk to other subjects. In any early termination, already enrolled subjects will continue to be followed per the stu... | [] |
NCT03624881 | 9.9 | Device Log | 9.9 Device Log | [] |
NCT03624881 | 9.9.1 | Device Log | 9.9.1 Device Log The Research sites will use their commercially available STSF/ST catheters per the approved IFU and SURPOINT COA Protocol requirements. The site will keep a device log of the catheter used during the study. The site Device Log will include the following information: - Catalog number for catheters - Ser... | [] |
NCT03624881 | 9.10 | Electronic Case Report Forms | 9.10 Electronic Case Report Forms Electronic CRFs (eCRFs) have been developed to capture the information outlined in this Study Protocol. Data on these eCRFs will be monitored, corrected if necessary, and entered into a validated database. All changes made to the data will be tracked in the electronic audit trail, reco... | [] |
NCT03624881 | 9.11 | Source Documentation | 9.11 Source Documentation Data entered into the eCRFs may be taken from source documentation, such as hospital procedure reports, admission and discharge summaries, and other hospital or physician office/clinic documents. If no standard hospital or office document exists to capture some of the information that may be u... | [] |
NCT03624881 | 9.12 | Subject Confidentiality/Record | 9.12 Subject Confidentiality/Record All representatives of the Sponsor have undergone training for Privacy regulations and appropriate conduct for their compliance. For the duration of this study, all representatives of the Sponsor will comply with all privacy regulations regarding contact with subjects, their medical ... | [] |
NCT03624881 | 9.13 | Data Management | 9.13 Data Management The Sponsor will be responsible for all data management activities. These activities include development of a database, utilizing validated database software, into which all study data will be entered by the clinicalsites. The Sponsor will be responsible for ensuring the overall integrity of the da... | [
"REFERENCES",
"APPENDIX A: STUDY DEFINITIONS"
] |
NCT03636490 | 1 | Study Purpose and Rationale | 1. Study Purpose and Rationale Blood pressure (BP) has a diurnal rhythm; it is normally highest during the daytime period and lowest during the nighttime period (BP dipping). The diurnal pattern of BP over a 24-hour period can be assessed using ambulatory BP monitoring (ABPM). Evidence indicates that an abnormal diurna... | [] |
NCT03636490 | 2 | Study Design | 2. Study Design The study will be conducted both in the laboratory and in the naturalistic environment with a multiethnic sample of 211 adult community participants from upper Manhattan who do not have a history of CVD, diabetes, chronic kidney disease, difficulty with blood draws, or another major medical condition an... | [] |
NCT03636490 | 3 | Study Procedures | 3. Study Procedures
a. Participant Engagement Interested individuals will review an online information sheet and provide consent to participate in an electronic eligibility screen. This form will provide the contact information of the primary investigator, clinical research coordinator, and IRB office to ensure that a... | [
"a. Participant Engagement",
"b. Blood, Urine, and Saliva Analysis",
"c. Providing Results to the Participant"
] |
NCT03636490 | 4 | Statistical Procedures | 4. Statistical Procedures Data Preparation: All variables will be reviewed for outliers and internally inconsistent values. Once a valid, final data set is compiled, variable distributions will be evaluated for non-normality and data transformations will be applied as needed. Winsorization may be employed to reduce the... | [
"Analytical Approach for Each Aim:"
] |
NCT03636490 | 5 | Risks | 5. Risks There may be risks or discomforts associated with taking part in this study. There may be minimal discomfort during and after the Laboratory Visit due to the blood pressure arm cuffs that are used in clinical blood pressure measurements and ambulatory blood pressure monitoring. The discomfort is temporary and ... | [
"Risk of Blood Draw",
"Risk from Sensitive Questions",
"Risk of Breach of Confidentiality"
] |
NCT03636490 | 6 | Benefits | 6. Benefits Participants will not receive personal (direct) benefit from taking part in this research study. However, the information collected from this research may help others in the future. | [] |
NCT03636490 | 7 | Alternatives | 7. Alternatives Participants may choose not to take part in this research study. | [] |
NCT03636490 | 8 | Data and Safety Monitoring | 8. Data and Safety Monitoring The research team will monitor the study to prevent any risks or dangers that may occur and will appropriately report any adverse events according to IRB policy. If a participant feels upset or experiences emotional distress, a member of the research team will be available to talk to them ... | [] |
NCT03637465 | A | Quick Guide to Data Collection | A Quick Guide to Data Collection Hydrate Philly will text you for data collection at 3 times over the next year… • Summer 2017: July 24 – August 4 • Spring 2018: TBD • Summer 2018: July/August Every data collection period lasts 10 days. During the period, we'll text you at 3:30 PM every day. Here's an example (with mad... | [
"Common Questions:",
"Hydrate Philly Water Fountain Observation Cheat Sheet",
"Hydrate Philly Water Fountain Observation Protocol",
"Overview of Observation Design",
"Observation Protocol",
"Appendix A – RA Observation Schedule",
"Hydration Station Maintenance Needs"
] |
NCT03658889 | 1 | INTRODUCTION AND RATIONALE FOR THE STUDY | 1 INTRODUCTION AND RATIONALE FOR THE STUDY Giant cell arteritis (GCA) - also known as temporal arteritis, cranial arteritis, or Horton's disease - is a form of immune-mediated inflammatory systemic vasculitis that affects large and mediumsized arteries, predominantly affecting the extracranial branches of the carotid a... | [] |
NCT03658889 | 2 | STUDY OBJECTIVES | 2 STUDY OBJECTIVES | [] |
NCT03658889 | 2.1 | Primary objective | 2.1 Primary objective The primary objective is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis. | [] |
NCT03658889 | 2.2 | Secondary objectives | 2.2 Secondary objectives The secondary objectives of this study are: - To describe comorbidities related to GCs and associated treatments - To describe GCA characteristics in terms of GCA duration, initial presentation, clinical form and GCA activity - To describe the health status of GCA patients - To describe physici... | [] |
NCT03658889 | 3 | STUDY METHODOLOGY | 3 STUDY METHODOLOGY | [] |
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