RecruitingNCT05935007
Aveir DR Real-World Evidence Post-Approval Study
Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
Sponsor
Abbott Medical Devices
Enrollment
1,805 participants
Start Date
Oct 31, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Eligibility Criteria:
- Implanted with an Aveir DR leadless pacemaker
- Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period
- Ability to link with Medicare fee-for-service data
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Interventions
DEVICEAveir DR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05935007
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