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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200049 / PAS001 |
| Date Original Protocol Accepted |
08/14/2021
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| Date Current Protocol Accepted |
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| Study Name |
Continued Follow-up of the Amulet IDE Cohort
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| Device Name |
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
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| Clinical Trial Number(s) |
NCT02879448
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| 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.
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| Study Population |
Patients were randomized to the Amulet device or the control Watchman device.
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| Sample Size |
2079 (already enrolled)
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| 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.
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
2079 subjects enrolled (No new enrollment for this study):
• 201 roll-ins
• 1878 randomized subjects (934 Amulet subjects, 944 subjects
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| Actual Number of Sites Enrolled |
115
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| Patient Follow-up Rate |
Actual follow-up rate at 5-year:
Amulet randomized subjects: 89.2%
Watchman randomized subjects: 83.3%
Roll-in subjects: 89.0%
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| Final Safety Findings |
Subject Deaths: There have been 251 Amulet and 261 Watchman subject deaths adjudicated by the CEC in the randomized group for the ITT population. Fourteen (14) of these deaths have been adjudicated as device-related or as having an unknown relationship to the device (5 Amulet and 9 Watchman). One Amulet subject death and one Watchman subject death were adjudicated as device-related, and the remainder were adjudicated as unknown relatedness to the device. As of the final 5-year visit, 27 deaths have been adjudicated as either related to or possibly related to COVID-19 in the randomized group (11 Amulet, 16 Watchman).
Serious Adverse Events (SAEs): A total of 542 Randomized Amulet subjects (58.0%) and 535 Randomized Watchman subjects (56.7%) experienced a SAE. Device-related SAEs occurred in 11.5% Randomized Amulet subjects and 10.1% Randomized Watchman subjects and procedure-related SAEs occurred in 9.0% Randomized Amulet subjects and 8.1% Randomized Watchman subjects. There have not been any reported unanticipated adverse events in the clinical trial. There have been 1233 SAEs in the Randomized Amulet group and 1142 SAEs in the Randomized Watchman group. The most common SAEs for both device groups were congestive heart failure (12.1% Amulet and 11.1% Watchman), gastrointestinal bleeds (10.5% Amulet and 10.5% Watchman), and ischemic stroke (6.1% Amulet and 5.6% Watchman). A total of 149 randomized Amulet subjects experienced a procedure- and/or device-related serious adverse event. Ischemic stroke (5.8%), pericardial tamponade (1.8%), and pericardial effusion (1.6%) were the most common procedure- or device-related SAEs. A total of 143 randomized Watchman subjects experienced a procedure- and/or device-related serious adverse event. Ischemic stroke (5.1%), transient ischemic attack (1.8%), and pericardial tamponade (1.5%) were the most common procedure- or device-related SAEs.
Non-Serious Adverse Events: A cumulative total of 401 non-serious adverse events were adjudicated in the randomized Amulet subject group and 351 non-serious adverse events in the randomized Watchman subject group. Epistaxis (4.0%), Gastrointestinal Bleeding (3.1%), and Bruise/ Purpura Simplex (2.8%) were the most commonly adjudicated non-serious adverse events in the randomized Amulet subject cohort. Gastrointestinal Bleeding (3.9%), Epistaxis (3.5%), Bruise/ Purpura Simplex (2.3%), and Hematuria (2.3%) were the most commonly adjudicated non-serious adverse events in the randomized Watchman subject cohort.
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| Final Effect Findings |
A total of 111 subjects experienced one or more components of the effectiveness endpoint: 58 in the Amulet group and 53 in the Watchman group, resulting in Kaplan-Meier estimated rates of 7.4% and 7.1%, respectively. The difference between the two groups was 0.3%. Ischemic stroke had a rate of 7.1% and 6.8% and systemic embolism rates of 0.3% and 0.4% for Amulet and Watchman, respectively.
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| Study Strengths & Weaknesses |
This study follows up the premarket cohort through five years post- procedure and provides
longer term safety and effectiveness results of the Amplatzer Amulet LAAO device
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| Recommendations for Labeling Changes |
Yes
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