Bachmann's Bundle Versus Right Atrial Appendage Pacing
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Study ID
- NCT07874763
- Status
- Recruiting
Conditions
- Atrial Fibrillation (AF)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bachmann's Bundle — DEVICEBBP
- Right Atrial Appendage Pacing — DEVICERAA pacing
Study Details
Participants will be randomly assigned to one of two clinical treatment Arms, both of which are standard care procedures performed in the right atrium (RA): Arm A: Pacing from the Bachmann's Bundle in the right atrium (upper right chamber of the heart) Arm B: Pacing from the right atrial appendage (a sac attached to the right atrium) Neither of these treatments are experimental; both are routinely performed by Electrophysiologists in the clinical setting. The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other. After the procedure, participants will be followed for one year. Medical record data will be collected, and a blood sample will be collected upon enrollment and at one year after implantation. Research-related surveys will be completed at the standard-care 3-, 6-, and 12-month visits.
Key Dates
- First listed
- Oct 15, 2026
- Start date
- Aug 19, 2025
- Status verified
- Oct 2026
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 334 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Bachmann's Bundle PacingStandard Clinical BB Pacing
- Active Comparator: Right Atrial Appendage PacingStandard Clinical RAA Pacing
Primary Outcome Measure
Cardiac Procedural Outcomes [ Time Frame: 12 months ]
Central Contacts
- Caitlin Phalunas, MS BME412-359-3747
- Heather McDonald, MHA CCRC412-513-5321
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | Heather McDonald, MHA CCRC Joshua Silverstein, MD (PRINCIPAL_INVESTIGATOR) |
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