NCT06100770 Aveir AR Coverage With Evidence Development (CED) Study
| NCT ID | NCT06100770 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Cardiac Pacemaker |
| Study Type | OBSERVATIONAL |
| Enrollment | 586 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2030-01 |
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 586 participants in total. It began in 2024-01-18 with a primary completion date of 2030-01.
⚠ 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 Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
Eligibility Criteria
Inclusion Criteria: 1. Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study. OR 2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial 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 NCT06100770 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 NCT06100770 currently recruiting?
Yes, NCT06100770 is actively recruiting participants. Contact the research team at nicole.harbert@abbott.com for enrollment information.
Where is the NCT06100770 trial being conducted?
This trial is being conducted at Sylmar, United States.
Who is sponsoring the NCT06100770 clinical trial?
NCT06100770 is sponsored by Abbott Medical Devices. The principal investigator is Nicole Harbert at Abbott. The trial plans to enroll 586 participants.