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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 Follow-up of the Amulet IDE Cohort


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P200049 / PAS001
Date Original Protocol Accepted 08/14/2021
Date Current Protocol Accepted  
Study Name Continued Follow-up of the Amulet IDE Cohort
Device Name Amplatzer™ Amulet™ Left Atrial Appendage Occluder
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of the Amulet IDE study to characterize the clinical outcomes annually through 5 years post-procedure of all available subjects who were enrolled in the randomized and roll-in cohorts of the Amulet IDE study.
Study Population Patients were randomized to the Amulet device or the control Watchman device.
Sample Size 2079 (already enrolled)
Key Study Endpoints Safety and effectiveness endpoints include: all-cause death, ischemic stroke, systemic embolism, major bleeding (Type 3 or greater per Bleeding Academic Research Consortium), procedure and device related complications, pericardial effusion requiring intervention, and device-related thrombus.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results Key Safety Findings:
Serious Adverse Events (SAEs):
There have been 2101 cumulative adjudicated SAEs in the randomized cohort, 1086 in the Randomized Amulet group and 1015 in the Randomized Watchman group. The most common SAEs were congestive heart failure (10.7%), gastrointestinal bleeds (9.7%), and ischemic stroke (5.1%).
Since the PMA cut-off date (November 2020), a total of 427 randomized subjects (594 events) experienced a SAE (219 Amulet subjects and 208 Watchman subjects).
Device-related SAEs occurred in 61 subjects (32 Amulet subjects and 29 Watchman subjects) and there have been 0 procedure-related SAEs since the PMA cut-off date.
Adverse Events (AEs):
A total of 734 non-serious adjudicated AEs in the randomized group. 388 AEs were adjudicated in the randomized Amulet subject group and 346 AEs in the randomized
Watchman subject group.
Since the PMA cut-off date, a total of 17 non-serious adverse events have been adjudicated in the randomized Amulet group and 24 non-serious adverse events in the randomized Watchman group. For randomized Amulet group, there were 2 device-related non-SAEs and
procedure-related events. For randomized Watchman group, there were 2 device-related non-SAEs.
Subject Deaths: There have been 389 subject deaths adjudicated by the CEC in the randomized group (184 Amulet subjects and 205 Watchman subjects). Thirteen (13) of these deaths have been adjudicated as device-related or as having an unknown relationship to the
device (5 Amulet and 8 Watchman). There were 70 new deaths (38 in the Amulet group and 32 in the Watchman group) since the previous report.
COVID-19 Related Deaths: As of the database cutoff for the report, 22 deaths have been adjudicated as either related to or possibly related to COVID-19 in the randomized group (11 Amulet, 11 Watchman). 9 of these COVID-19 related deaths were new from the previous report.
Key Effectiveness Findings:
100% (449/449) achieved 6-month clinical closure success
79 subjects experienced one or more components of the effectiveness endpoint: 42 in the
Amulet group and 37 in the Watchman group.
Ischemic stroke had a rate of 4.7% and 4.5% and systemic embolism had a rate of 0.3% and
0.2% for Amulet and Watchman subjects, respectively.
Actual Number of Patients Enrolled There is no new enrollment for this study, as it involves only follow-up of the premarket cohort. However, a total of 2079 were enrolled in the premarket study.
Actual Number of Sites Enrolled There are no new study sites for this study, as it involves only study subjects from the premarket cohort. The study subjects were enrolled at 114 sites in the premarket study.
Patient Follow-up Rate For Amulet randomized subjects: 3-year: 93.1%, 4-year: 92.3%, 5-year: 93.9%
For Watchman randomized subjects: 3-year: 89.0%, 4-year: 89.5%, 5-year: 90.0%
For Roll-in subjects: 3-year: 94.5%, 4-year: 91.5%, 5-year: 90.5%


Continued Follow-up of the Amulet IDE Cohort 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 08/11/2022 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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