Recruiting

Bachmann's Bundle vs. Right Atrial Appendage

Sponsor:

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Code:

NCT07874763

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bachmann's Bundle

Right Atrial Appendage Pacing

Study Details

Brief summary:

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.

Conditions

Atrial Fibrillation (AF)

Study ID

NCT07874763

Start date

Aug 19, 2025

Status verified date

Oct, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing a de novo CIED (i.e. pacemaker, ICD, CRT) implant with an atrial lead
  • Medtronic CIED system used
  • Age 18 years or older
  • Able to read and understand English AND EITHER 1)willing and capable of providing informed consent OR 2) in case of incompetence, be represented by a legally authorized representative (LAR), relative/associate with power of attorney (POA), or other recognized surrogate decision-maker who can read and understand English and is willing and capable of providing consent.
  • Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study

Exclusion Criteria:

  • Prior CIED implant
  • Known pericarditis or pericardial effusion
  • NYHA Functional Class IV
  • Severe valvular disease expected to require surgical intervention within 12 months.
  • History of abnormal bleeding and/or clotting disorder
  • Severe lung disease, pulmonary hypertension, or any lung disease requiring home supplemental oxygen.
  • Organ or hematologic transplant, or currently being evaluated for an organ transplant
  • Women who are pregnant or breastfeeding. This will be assessed clinically as per pre-procedure clinical workflow, and the research coordinator will capture the data.

Study Design

Enrollment

334 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Bachmann's Bundle Pacing

Standard Clinical BB Pacing

active comparator: Right Atrial Appendage Pacing

Standard Clinical RAA Pacing

Interventions

Bachmann's Bundle

BBP

Right Atrial Appendage Pacing

RAA pacing

Primary outcome measure

  • Cardiac Procedural Outcomes [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Caitlin Phalunas, MS BME

412-359-3747caitlin.phalunas@ahn.org

Heather McDonald, MHA CCRC

412-513-5321heather.mcdonald@ahn.org

Locations

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Heather McDonald, MHA CCRC

412-513-5321heather.mcdonald@ahn.org

Heather McDonald, MHA CCRC

heather.mcdonald@ahn.org

Principal Investigator:

Joshua Silverstein, MD

More Information

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • Atrial Pacing
  • Atrial Fibrillation
  • AF
  • Cardiac Resynchronization Therapy
  • CRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.