Cardiac PacemakerHeart and circulationDevice
What this study is
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.
What's being tested
- Aveir DR Leadless Pacemaker System
Intervention · DEVICE
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.
Study details
- Official title
- Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
- Sponsor
- Abbott Medical Devices
- Conditions
- Cardiac Pacemaker · Arrythmia · Bradycardia
- Enrolling
- 1,805 people
- Starts
- 2023-10-31
- Est. completion
- 2030-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAbbott
Sylmar, California, United States
- Nicole Harbert · Contact972-526-4841Nicole.Harbert@abbott.com
Recruiting
Study team
Sponsor
Abbott Medical Devices
Study ID ABT-CIP-10454
Study director
Nicole Harbert
Abbott
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.