NCT05935007 Aveir DR Real-World Evidence Post-Approval Study
| NCT ID | NCT05935007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Cardiac Pacemaker |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,805 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 1,805 participants in total. It began in 2023-10-31 with a primary completion date of 2030-12-31.
⚠ 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 post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
Eligibility Criteria
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
Contact & Investigator
Nicole Harbert
STUDY DIRECTOR
Abbott
Frequently Asked Questions
Who can join the NCT05935007 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 NCT05935007 currently recruiting?
Yes, NCT05935007 is actively recruiting participants. Contact the research team at nicole.harbert@abbott.com for enrollment information.
Where is the NCT05935007 trial being conducted?
This trial is being conducted at Sylmar, United States.
Who is sponsoring the NCT05935007 clinical trial?
NCT05935007 is sponsored by Abbott Medical Devices. The principal investigator is Nicole Harbert at Abbott. The trial plans to enroll 1,805 participants.