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General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P150035 S013/ PAS001 |
Date Original Protocol Accepted |
11/22/2024
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Date Current Protocol Accepted |
 
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Study Name |
Aveir DR Real-World Evidence Study
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Device Name |
Aveir™ Leadless System (Dual-Chamber)
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General Study Protocol Parameters |
Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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Data Source |
Other Data Source
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Comparison Group |
No 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 |
This study utilizes a real-world evidence method merging multiple real-world datasets from Abbott and CMS to assess the safety of the Aveir DR LP in a large patient population.
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Study Population |
All de novo patients who had an implant of both Aveir DR devices, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis of this endpoint.
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Sample Size |
Number of subjects: 1,805 patients Assumptions for sample size estimation: Assuming an underlying complication-free rate of 85% at 5 years, 900 evaluable subjects will provide at least 85% power to meet a performance goal of 81% and reject the null hypothesis at a 2.5% one-sided significance level. The sample size calculation is based on the normal approximation to the binomial distribution. Number of sites: N/A Sites location: N/A
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Key Study Endpoints |
Primary: The primary endpoints are: ¿ Key acute complications through 30 days post implant procedure ¿ Freedom from key chronic complications from 31 days through 5 years post implant procedure Secondary: The secondary endpoints are ¿ Complication rate of the Aveir DR LP for key individual acute and chronic complications ¿ Care of subjects at the end of device service Descriptive: 1. Rates of other procedure-related acute complications 2. Survival at 5 years 3. Device longevity 4. Device longevity by device (atrial, ventricular) 5. Acute complications by device (atrial, ventricular) 6. Chronic complications by device (atrial, ventricular) Additional analyses: 1. Cohort demographics and comorbidities 2. Device-device interaction 3. Effect of implanter experience with DR leadless pacemakers 4. Acute and chronic complications in patients with an atrial LP only 5. Battery performance 6. i2i performance 7. Acute and chronic complications in all Aveir patients (de novo and non de novo) 8. Complications from cross talk occurring in patients programmed to AAI+VVI mode
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Follow-up Visits and Length of Follow-up |
5 years
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