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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 |
Key Safety Findings: . Adverse Events (AEs) AE counts as reported by the LAAO registry in-hospital (defined as any AE at the index procedure through when the patient was discharged from the hospital): 146 patients (6.0%) had an in-hospital AE. The most frequently reported AEs by preferred term included pericardial effusion with no intervention (1.1%), pericardial effusion with tamponade (requiring percutaneous drainage) (0.7%), and respiratory failure (0.4%). The rate of early pericardial effusion (in-hospital) that required intervention was 1.0%. AE counts reported at 45 days : 283 patients (16.5%) that have crossed the 45-day visit had an AE. The most frequently reported AEs by preferred term included nondevice-related readmission (9.2%), GI bleeding (2.3%), and pericardial effusion w/ tamponade (requiring percutaneous drainage) (0.8%). The rate of late pericardial effusion (45-day visit) that required intervention was 1.1%. AE counts reported at 6 months : 61 patients (25.9%) that have crossed the 6-month visit had an AE. The most frequently reported AEs by preferred term included nondevice-related readmission (18.2%), GI bleeding (3.8%), and pulmonary embolism (1.3%). Device thrombus occurred in only 1 patient (0.04%). . Deaths A total of 38 deaths were reported as of the cut-off date. Most deaths occurred during follow-up (31 of the 38 deaths). The primary causes of death as reported by the sites in the LAAO registry through the cut-off date were other cardiovascular reasons (4), pulmonary (2), cardiovascular hemorrhage (1), and not specified (31). Key Effectiveness Findings: The rate of implant success was 96.8% with 99.96% of patients with =5mm residual leak around the device post-procedure. At follow-up, 99.7% of patients had =5mm residual leak at 45 days.
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Actual Number of Patients Enrolled |
From August 14, 2021 through December 15, 2023, 12,021 patients were enrolled.
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Actual Number of Sites Enrolled |
348 sites have enrolled subjects as of the cut-off date
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Patient Follow-up Rate |
• Of the 12,021 patients with an Amulet attempted procedure • 11,991 (99.8%) patients were documented as completing the hospitalization visit (episode of care) • 8,654 (of the 8,934 alive and reached visit window) patients completed their 45-day visit (96.9%) • 5,708 (of the 5,997 alive and reached the visit window) patients completed their 6-month visit (95.2%) • 2,924 (of the 3,113 alive and reached the visit window) patients completed their 1-year visit (93.9%) • 131 (of the 142 alive and reached the visit window) patients completed their 2-year visit (92.3%) as of the cut-off date
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Final Safety Findings |
Adverse Events (AEs) • 629 patients (5.23%) had an in-hospital AE. • The most frequently reported AEs by preferred term included pericardial effusion with no intervention (1.57%), pericardial effusion with tamponade (requiring percutaneous drainage) (1.31%), and cardiac arrest (0.39%). • The rate of early pericardial effusion (in-hospital) that required intervention was 1.5%. • AEs related to the device including device explant, device migration, device thrombus, device system embolization (catheter retrieval) and device system embolization (surgical retrieval) occurred in 0.20% (n=24), 0.15% (n=18), 0.1.5% (n=18), and 0.11% (n=13), and 0.13% (n=16) patients respectively. AE counts reported at 45 days • A total of 2,412 patients (27.87%) that have crossed the 45-day visit had an AE. • The most frequently reported AEs by preferred term included non-device-related readmission (20.35%), GI bleeding (3.47%), and pericardial effusion with or without tamponade (requiring percutaneous drainage) (2.42%). • AEs related to the device including device thrombus, device systemic embolization, and device migration occurred in 0.91% (n=79), 0.21% (n=18), and 0.21% (n=18) patients, respectively. AE counts reported at 6 months • A total of 1,881 patients (32.95%) that have crossed the 6-month visit had an AE. • The most frequently reported AEs by preferred term included non-device related readmission (25.28%), GI bleeding (4.1%), and pericardial effusion with or without tamponade (requiring percutaneous drainage (2.40%). Device thrombus occurred in only 63 patients (1.10%). Deaths • A total of 475 deaths (3.95%) were reported as of the cut-off date. • 30 deaths (0.25%) occurred in-hospital with most occurring during follow-up (445 of the 475 deaths). • The primary causes of death as reported by the sites in the LAAO registry through the cut-off date were non-cardiovascular reasons (155), pulmonary (40), other cardiovascular reasons (39), and sudden cardiac death (37).
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Final Effect Findings |
Procedural Outcomes – device closure • 482 (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: • 97.5% having complete closure (0mm) • 2.4% with a small leak (0-5mm) • 5 patients (0.04%) with a large leak (>5mm). Follow-up Assessments • At 45 days, the device maintained complete closure (0mm) in 85.6% of patients, 13.9% had a small leak (0-5mm), and 26 patients (0.5%) had a large leak (>5mm). • Of the 460 patients that have had device closure assessed at 1 year, 375 (81.5%) patients had complete closure, 80 (17.4%) patients had a small leak, and 5 (1.1%) patients had a large leak.
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