Evaluating the Aveir Leadless Pacemaker for Medicare Patients
The AVEIR DR Coverage With Evidence Development (DRIVE) Study
Abbott Medical Devices · NCT05932602
This study is trying to see how well the Aveir Leadless Pacemaker works and what problems it might cause for Medicare patients compared to traditional pacemakers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2812 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices (industry) |
| Locations | 1 site (Sylmar, California) |
| Trial ID | NCT05932602 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the complications and long-term health outcomes associated with the dual chamber Aveir Leadless Pacemaker device among Medicare beneficiaries. By utilizing real-world evidence methods, the study merges multiple datasets from Abbott and the Center for Medicare Services to gather comprehensive health outcome data. It will enroll Medicare patients who have received either the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer, without requiring individual patient consent due to an approved waiver. The study focuses on understanding the effectiveness and safety of these pacemaker systems in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are Medicare beneficiaries who have been implanted with the Aveir DR leadless pacemaker or a dual-chamber transvenous pacemaker.
Not a fit: Patients who do not meet the criteria of being Medicare beneficiaries or who have not received the specified pacemaker systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the Aveir Leadless Pacemaker, potentially improving patient outcomes.
How similar studies have performed: Other studies utilizing real-world evidence approaches have shown promise in evaluating medical devices, suggesting that this methodology could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: None
Where this trial is running
Sylmar, California
- Abbott — Sylmar, California, United States (RECRUITING)
Study contacts
- Study coordinator: Nicole Harbert
- Email: nicole.harbert@abbott.com
- Phone: 972-526-4841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Pacemaker, Arrythmia, Bradycardia, dual chamber, sick sinus rhythm, pacemaker, AV Block