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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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ODE Lead-Continued f/u of IDE Cohorts


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General
Study Status Progress Adequate
Application Number P130013 / PAS001
Study Name ODE Lead-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


ODE Lead-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
CAP 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   Overdue
3 year report 03/12/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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