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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200049 / PAS002 |
| Date Original Protocol Accepted |
12/09/2021
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| Date Current Protocol Accepted |
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| Study Name |
Amulet Real-World Use Surveillance
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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 |
Prospective Cohort Study
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| Data Source |
External Registry
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| Comparison Group |
Objective Performance Criterion
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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 |
Comprehensive/Linked/Registry Based Surveillance
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| Study Population |
Patients with attempted implant of the Amulet device enrolled at sites participating in the LAAO registry.
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| Sample Size |
All consecutive patients treated within the first 2 years that are entered into the LAAO Registry.
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| 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
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| 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).
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Adverse Events (AEs):
AE counts reported in-hospital:
• 631 patients (5.18%) had an in-hospital AE.
• The most frequently reported AEs by preferred term included pericardial effusion with no intervention (1.55%), pericardial effusion with tamponade (requiring percutaneous drainage) (0.90%), without tamponade requiring percutaneous drainage (0.39%), and requiring open cardiac surgery (0.21%).
• The rate of early pericardial effusion (in-hospital) that required intervention was similar in the registry (n=167 for 1.4%) compared to the rate of early pericardial effusion (0-2 days post procedure) that required intervention in the Amulet IDE trial (1.3%).
• AEs related to the device included device explant (0.21%), device migration (0.15%), device thrombus (0.15%), device system embolization (catheter retrieval) (0.11%) and device system embolization (surgical retrieval) (0.13%).
AE counts reported at 45 days:
• A total of 3,594 patients (37.94%) that have crossed the 45-day visit had an AE.
• The most frequently reported AEs by preferred term included non-device-related readmission (30.62%), GI bleeding (4.43%), and pericardial effusion with tamponade (requiring percutaneous drainage) (1.53%).
• AEs related to the device included device explant (0.38%), device systemic embolization (0.24%), and device migration (0.23%).
AE counts reported at 6 months:
• A total of 3290 patients (39.12%) that have crossed the 6-month visit had an AE.
• The most frequently reported AEs by preferred term included non-device related readmission (32.12%), GI bleeding (4.45%), and pericardial effusion (no intervention required) (1.56%).
• Device thrombus occurred in 93 patients (1.11%).
AE counts reported through 1-year:
• A total of 2751 patients (40.06%) that crossed the 1-year visit have had an AE.
• At 1-year, the most frequently reported AEs by preferred term included non-device related readmission (33.24%), GI bleeding (4.44%), and pericardial effusion with tamponade (requiring percutaneous drainage) (1.56%).
• Ischemic stroke occurred in 1.47% and device thrombus in 1.19% of patients.
Deaths:
• A total of 908 deaths were reported as of the cut-off date.
• 29 deaths occurred in-hospital with most (879) occurring during follow-up.
• The primary causes of death as reported by the sites in the LAAO registry through the cut-off date were non-cardiovascular reasons (303), pulmonary (76), other cardiovascular reasons (68), and heart failure (64).
Effectiveness Results:
Procedural Outcomes:
• 485 (4.0%) procedures were aborted with the most common reason for aborting the procedure as the anatomy was not conducive for an implant (n=383).
• 15 (0.1%) procedures led to a conversion to an open-heart surgery.
Residual leaks after implant:
• 97.6% had complete closure (0mm)
• 2.4% had a small leak (0-5mm)
• 5 patients (0.04%) had a large leak (>5mm).
Follow-up Assessments:
• Of the 5204 patients that have had device closure assessed at 45 days, the 4445 (85.4%) patients had complete closure, 731 (14.0%) had a small leak (0-5mm), and 28 patients (0.5%) had a large leak (>5mm).
• Of the 1029 patients that have had device closure assessed at 1 year, 849 (82.5%) patients had complete closure, 172 (16.7%) patients had a small leak (0-5mm), and 8 (0.8%) patients had a large leak (>5mm).
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| Actual Number of Patients Enrolled |
From August 14, 2021, through March 28, 2025, 12,180 patients were enrolled
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| Actual Number of Sites Enrolled |
350 sites have enrolled subjects as of the cut-off date
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| Patient Follow-up Rate |
Of the 12,180 patients with an Amulet attempted procedure:
• 12,151 (99.8%) patients were documented as completing the hospitalization visit (discharge visit)
• 9,474 (of the 9,783 alive and reached visit window) patients completed their 45-day visit (96.8%)
• 8,409 (of the 8,876 alive and reached the visit window) patients completed their 6-month visit (94.7%)
• 6,868 (of the 7,340 alive and reached the visit window) patients completed their 1-year visit (93.6%)
• 2,341 (of the 2,604 alive and reached the visit window) patients completed their 2-year visit (89.9%) as of the data call date
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