An interventional study of Bachmann's Bundle Pacing and Right Atrial Appendage Pacing in Atrial Fibrillation (AF), sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Treatment
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 (BB) in the right atrium (upper right chamber of the heart) Arm B: Pacing from the right atrial appendage (RAA - 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.
Patients requiring cardiac resynchronization therapy (CRT) will screened for the study prior to any research procedures. Once consent has been granted, participants will be randomly assigned to Arm A (BB pacing) or Arm B (RAA pacing). After the procedure, they will have post-implantation visits at 3, 6, and 12 months.
The purpose of the study is to compare the safety of Bachmann bundle versus right atrial appendage lead placement to reduce the incidence of the composite outcome of cardiac perforation, pericarditis, lead dislodgement, pericardial effusion, lead revision, and all-cause mortality within 12-month of follow-up
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 334 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 47 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Standard Clinical BB Pacing
Device: Bachmann's Bundle Pacing
Standard Clinical RAA Pacing
Device: Right Atrial Appendage Pacing
BB Pacing
RAA Pacing
Cardiac Procedural Outcomes
The primary endpoint is freedom from cardiac perforation, pericarditis, lead dislodgement, lead revision, and all-cause mortality within 12-months of randomization.
Time frame: 12 months
Acute Success
Acute success (fluoroscopy vs electrogram method) (Binary: yes/no)
Time frame: 24 hours
P-wave function
Change in P-wave duration (milliseconds)
Time frame: 24 hours
Atrial fibrillation (AF)/atrial flutter (AFl) progression
Incidence of AF/ AFl progression (percentage)
Time frame: 12 months
Fluoroscopy time
Procedure and total fluoroscopy time (min/s)
Time frame: 24 hours
Lead positions
Number of lead positions attempted (whole number)
Time frame: 24 hours
Atrial pacing
Percentage atrial pacing (percentage)
Time frame: 12 months
Adverse events (AEs)
AEs (e.g. pocket revisions and hematomas) (whole number)
Time frame: 12 months
Plan to share: No — We will share aggregated data with any potential collaborators who may join the study. We will not share individual data.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Aug 2027, 24 months after the start.
Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 24 months is below that.
Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)