| NCT ID | NCT07106788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Leadless Pacemaker |
| Study Type | OBSERVATIONAL |
| Enrollment | 304 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2029-11 |
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 304 participants in total. It began in 2025-05-26 with a primary completion date of 2029-11.
⚠ 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 primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.
Eligibility Criteria
Inclusion Criteria: * Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system * Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study * Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system Exclusion Criteria: * N/A
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07106788 clinical trial?
This trial is open to participants of all sexes, studying Leadless Pacemaker. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07106788 currently recruiting?
Yes, NCT07106788 is actively recruiting participants. Contact the research team at mieko.otake@abbott.com for enrollment information.
Where is the NCT07106788 trial being conducted?
This trial is being conducted at Nagoya, Japan, Kitakyushu, Japan, Kawasaki, Japan, Sendai, Japan and 10 additional locations.
Who is sponsoring the NCT07106788 clinical trial?
NCT07106788 is sponsored by Abbott Medical Devices. The trial plans to enroll 304 participants.