AVEIR DR Coverage With Evidence Development (CED) Study
The AVEIR DR Coverage With Evidence Development (DRIVE) Study
Abbott Medical Devices
2,812 participants
Oct 31, 2023
OBSERVATIONAL
Conditions
Summary
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
Eligibility
Inclusion Criteria3
- Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.
- OR
- Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date
Exclusion Criteria1
- None
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Interventions
This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention is required in this study.
This study will utilize real-world data from patients implanted with a dual-chamber transvenous pacemaker as a comparator to the Aveir DR LP system study arm. No device intervention is required in this study.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05932602