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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200049 / PAS002 |
| Date Original Protocol Accepted |
12/09/2021
|
| Date Current Protocol Accepted |
|
| Study Name |
Amulet Real-World Use Surveillance
|
| Device Name |
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Comprehensive/Linked/Registry Based Surveillance
|
| Study Population |
Patients with attempted implant of the Amulet device enrolled at sites participating in the LAAO registry.
|
| Sample Size |
All consecutive patients treated within the first 2 years that are entered into the LAAO Registry.
|
| 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
|
| 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).
|
| 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.
|
| Actual Number of Patients Enrolled |
From August 14, 2021, through June 30, 2022, 2,414 patients were enrolled into this
Amulet Real-World Use Surveillance PAS study.
|
| Actual Number of Sites Enrolled |
151 sites have enrolled subjects as of the cut-off date
|
| Patient Follow-up Rate |
Of the 2414 patients with an Amulet attempted procedure:
o 2407 (99.7%) patients were documented as completing the hospitalization visit
(episode of care)
o 1714 (71.9%) patients completed their 45-day visit
o 236 (9.9%) completed the 6-month visit although most have not crossed the
outside 6-month visit window as of the cut-off date.
|
| Study Strengths & Weaknesses |
The results from this study provide the long-term safety and effectiveness of the
Amulet occluder in a contemporary real-world setting.
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