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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Continued f/u of IDE Cohorts


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General
Study Status Completed
Application Number P130013 / PAS001
Study Name Continued f/u of IDE Cohorts
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohorts in one randomized controlled trial (PREVAIL) and two continued access single arm registries (CAP and CAP2). The objective of these studies is to characterize the safety and effectiveness of the WATCHMAN LAA Closure Technology annually through 5 years post-procedure.
Study Population Description Patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism and are eligible for warfarin therapy. All patients in CAP and CAP2 were designated to receive the device. PREVAIL patients were randomized to either the device or long-term warfarin therapy.
Sample Size Initial enrollment in the premarket studies was as follows:
CAP: 566
PREVAIL: 407 (269 in device group, 138 in control group)
CAP2: 579
Data Collection Primary Endpoints (CAP):
- stroke, systemic embolism, and cardiovascular or unexplained death
- life threatening events as determined by the Clinical Events Committee (such as device embolization requiring retrieval, pericardial effusion requiring drainage, cranial bleeding, gastrointestinal bleeding requiring transfusion, and any bleeding related to the device/procedure that necessitates an operation)
Primary Endpoints (PREVAIL and CAP2):
- stroke, systemic embolism, and cardiovascular or unexplained death
- ischemic stroke and systemic embolism occurring more than 7 days post-enrollment
Secondary Endpoints:
- complete and effective LAA closure rate
- warfarin discontinuation rate
- warfarin or other oral anticoagulation resumption rates and reasons
- device thrombus rates and outcomes
Follow-up Visits and Length of Follow-up Follow-up will continue through 5 years post-procedure
PREVAIL/CAP2: post-enrollment intervals of 45 days, 6 months, 12 months, semi-annually through 3 years, and therafter annually through 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled CAP: A total of 566 subjects implanted with the WATCHMAN Left Atrial Appendage Closure Technology constituted the post-approval study population.
PREVAIL: A total of 461 subjects were enrolled with 407 randomized and the remaining 54 participating in the
WATCHMAN Roll-in group. Of the 407 randomized subjects, 269 were assigned to the WATCHMAN group and
138 assigned to the warfarin control group. Of the 269 subjects randomized to the WATCHMAN group, 252
subjects received a WATCHMAN device.
CAP2: A total of 578 subjects implanted with the WATCHMAN Left Atrial Appendage Closure Technology
constituted the post-approval study population.
Actual Number of Sites Enrolled CAP: 26 sites
PREVAIL: 41 sites
CAP2: 48 sites
Patient Follow-up Rate CAP: 86.0% (487/566) of subjects completed the 5 year
visit.
PREVAIL: 87.4% (235/269) of the device group and 81.8%
(112/137) of the control group completed the 5 year visit.
CAP2: 84.4% (488/578) of subjects completed the 5 year
visit.
Final Safety Findings CAP: The primary safety endpoint was defined as the occurrence of life-threatening events as determined by the
Clinical Events Committee, which included the following events: device embolization requiring retrieval, bleeding
events such as pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal
bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.
Freedom from the primary safety endpoint was 87.4% at 5 years.
PREVAIL: The occurrence of all-cause death, ischemic stroke, systemic embolism, or device or procedure related
events requiring open cardiac surgery or major endovascular intervention between the time of randomization and within 7 days of the procedure or by
hospital discharge, whichever is later, was 2.2% (6/269) (95% CI: 0.6%, 2.7%). This analysis was only performed for
the device group.
CAP2: The CAP2 safety endpoint was the same as PREVAIL. The rate of the safety endpoint was 1.4% (8/576)
(95% CI: 0.6%, 2.7%).
Final Effect Findings CAP: Freedom from stroke (ischemic and hemorrhagic), systemic embolism, and cardiovascular/unexplained death
was 86.3% at 5 years. PREVAIL: Freedom from the first primary endpoint (hemorrhagic stroke, ischemic stroke, systemic embolism or
cardiovascular/unexplained death) through 5 years was 83.5% (95% CI: 78.1, 87.7) in the intent-to-treat (ITT) device
group and 86.2% (95% CI: 78.4, 91.4) in the control group.
Freedom from the second primary endpoint (ischemic stroke or systemic embolism after 7 days following randomization)
through 5 years was 92.1% (95% CI: 87.7, 94.9) in the device group and 96.3% (95% CI: 90.4, 98.6) in the control
group.
CAP2: Freedom from the first primary endpoint (same as PREVAIL) through 5 years was 78.2% (74.2%, 81.7%) in
the ITT group.
Freedom from the second primary endpoint (same as PREVAIL) in the ITT group was 90.2% (95% CI: 87.2, 92.5) at 5 years.
Of subjects successfully implanted with WATCHMAN and followed for 5 years, 94.8% of CAP subjects, 98% of
PREVAIL subjects, and 97.1% of CAP2 subjects discontinued warfarin therapy at 5 years.
Study Strengths & Weaknesses A strength of all three studies (CAP, PREVAIL, and CAP2) is that they provided results on the long-term (5 years)
safety and efficacy of the device.
A weakness of CAP was that there was no pre-specified safety endpoint. A weakness of the CAP and CAP2 studies
was that these studies are single-arm (non-randomized) studies.
Recommendations for Labeling Changes A labeling change is recommended to add the long-term safety and efficacy results from the pre-market cohort


Continued f/u of IDE Cohorts Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
4 month report 07/12/2015 07/14/2015 Overdue/Received
8 month report 11/10/2015 11/19/2015 Overdue/Received
interim report 12/01/2015 12/01/2015 On Time
one year report 03/12/2016 03/11/2016 On Time
16 month report 07/11/2016 07/15/2016 Overdue/Received
20 month report 11/09/2016 11/14/2016 Overdue/Received
two year report 03/12/2017 03/08/2017 On Time
28 month report 07/11/2017 07/10/2017 On Time
32 month report 11/10/2017 11/13/2017 Overdue/Received
3 year report 03/12/2018 03/08/2018 On Time
40 month report 07/11/2018 07/10/2018 On Time
44 month report 11/11/2018 11/08/2018 On Time
4 year report 03/12/2019 03/08/2019 On Time
52 month report 09/03/2019 08/14/2019 On Time
56 month report/FINAL 01/03/2020 11/12/2019 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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