f Post-Approval Studies (PAS) Database
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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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Amulet Real-World Use Surveillance


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General
Study Status Study Pending
Application Number /
Requirement Number
P200049 / PAS002
Date Original Protocol Accepted 12/09/2021
Date Current Protocol Accepted  
Study Name Amulet Real-World Use Surveillance
Device Name Amplatzer™ Amulet™ Left Atrial Appendage Occluder
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Comprehensive/Linked/Registry Based Surveillance
Study Population Patients with attempted implant of the Amulet device enrolled at sites participating in the LAAO registry.
Sample Size All consecutive patients treated within the first 2 years that are entered into the LAAO Registry.

Key Study Endpoints Primary endpoints include the following:
1. Primary safety: composite of procedure-related complications, or all-cause death, or major bleeding (defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition) through 12 months
2. Primary effectiveness: composite of ischemic stroke or systemic embolism through 18 months
3. Device closure: device closure rate at the 45-day visit
4. Pericardial effusion: rate of pericardial effusion events requiring intervention through 2 years
Follow-up Visits and Length of Follow-up The applicant has agreed to link the data to the Centers for Medicare and Medicaid Services (CMS) claims database for long-term surveillance of these patients through 5 years post implantation (follow-up duration).


Amulet Real-World Use Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/12/2022 02/11/2022 On Time
1 year report 08/14/2022 08/12/2022 On Time
18 month report 02/12/2023    
2 year report 08/14/2023    
3 year report 08/13/2024    
4 year report 08/13/2025    


Contact Us

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

Additional Resources

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