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Bachmann's Bundle Versus Right Atrial Appendage Pacing

BACHmann Bundle Versus Right Atrial Appendage Pacing Randomized Controlled Trial: Learning Curve, Safety, Efficacy, Physiological Effect, and Transthoracic Echo Guidance

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Patients undergoing a de novo cardiac implantable electronic device (CIED) (i.e. pacemaker, implantable cardioverter-defibrillator (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
* New York Heart Association (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.

About the study

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.

What is being tested

• Bachmann's Bundle Pacing (device)
• Right Atrial Appendage Pacing (device)

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Participants: 334 · Started: Aug 19, 2025

Contact the study team

• Caitlin Phalunas, MS BME · Phone: 412-359-3747
• Heather McDonald, MHA CCRC · Phone: 412-513-5321

Official record on ClinicalTrials.gov — NCT07874763

Locations in the U.S.

Conditions

• Atrial Fibrillation

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.