NCT05336877 Aveir VR Coverage With Evidence Development Post-Approval Study
| NCT ID | NCT05336877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Cardiac Pacemaker |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,744 participants |
| Start Date | 2022-06-21 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8,744 participants in total. It began in 2022-06-21 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
Eligibility Criteria
The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location Inclusion Criteria: Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study. OR Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date Exclusion Criteria: None
Contact & Investigator
Nicole Harbert
STUDY DIRECTOR
Abbott
Frequently Asked Questions
Who can join the NCT05336877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Pacemaker. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05336877 currently recruiting?
Yes, NCT05336877 is actively recruiting participants. Contact the research team at nicole.harbert@abbott.com for enrollment information.
Where is the NCT05336877 trial being conducted?
This trial is being conducted at Sylmar, United States.
Who is sponsoring the NCT05336877 clinical trial?
NCT05336877 is sponsored by Abbott Medical Devices. The principal investigator is Nicole Harbert at Abbott. The trial plans to enroll 8,744 participants.