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| General |
| Study Status |
Ongoing |
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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| 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: >21
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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 |
| Interim Results |
Serious Adverse Events (SAEs):
• There have been 2250 all cumulative adjudicated SAEs for randomized subjects, 1168 in the Randomized Amulet group and 1082 in the Randomized Watchman group. The most common SAEs were congestive heart failure (11.3%), gastrointestinal bleeds (10.1%), and ischemic stroke (5.4%).
• Since the PMA cut-off date (November 2020), a total of 515 randomized subjects (741 events) experienced a SAE (265 Amulet subjects and 250 Watchman subjects). Device-related SAEs occurred in 70 subjects (36 Amulet subjects and 34 Watchman subjects) and there have been 0 procedure-related SAEs since the PMA cut-off date. Ischemic stroke and transient ischemic attack are the most common device-related SAEs for both the randomized Amulet group and the randomized Watchman group.
Adverse Events (AEs):
• Since the PMA cut-off date, a total of 25 non serious adverse events have been adjudicated in the randomized Amulet group and 26 non-serious adverse events in the randomized Watchman group. For randomized Amulet group, there were 3 device-related non-SAEs (2 device malposition or malfunction and 1 transient ischemic attack) and 0 procedure-related events. For randomized Watchman group, there were 2 device-related non-SAEs (2 transient ischemic attacks).
• There have been 739 non-serious adjudicated AEs. 392 AEs were adjudicated in the randomized Amulet subject group and 347 AEs in the randomized Watchman subject group. Epistaxis, Gastrointestinal Bleeding, and Bruise/ Purpura Simplex were the most adjudicated non-serious adverse events in the randomized subjects.
Subject Deaths:
• There have been 460 subject deaths adjudicated by the CEC in the randomized group (222 Amulet subjects and 238 Watchman subjects). 14 of these deaths have been adjudicated as device-related or as having unknown relationship to the device (6 Amulet and 8 Watchman). There were 44 new deaths in the Amulet group and 22 in the Watchman group since the previous report. None of these new deaths were device related.
• COVID-19 Related Deaths: As of the database cutoff for the report, 26 deaths have been adjudicated as related COVID-19 in the randomized group (11 Amulet, 15 Watchman). 3 new COVID-19 related death (all Watchman) since the previous report.
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| 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 |
114 total incl. 84 US, 30 OUS (no change from the IDE study)
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| Patient Follow-up Rate |
Randomized Amulet subjects:
• 4-year visit: 91.3% (647/676)
• 5-year visit: 92.6% (339/349)
Randomized Watchman subjects:
• 4-year visit: 88.0% (597/622)
• 5-year visit: 88.5% (304/314)
Roll-in subjects:
• 4-year visit: 93% (141/143)
• 5-year visit: 92.5% (112/115)
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| Final Effect Findings |
• At 4-year post procedure, 98 subjects experienced one or more component of the effectiveness endpoint: 51 in the Amulet group and 47 in the Watchman group.
• At 4- year post procedure, ischemic stroke had a rate of 5.9% and 5.8 % 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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