Bachmann's Bundle Versus Right Atrial Appendage Pacing

NCT07874763 | Recruiting FDA Device

• 1 other identifier: 2025-180
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (7)

• Acute Success

  24 hours

• P-wave function

  24 hours

• AF/AFl progression

  12 months

• Fluoroscopy time

  24 hours

• Lead positions

  24 hours

Study Arms (2)

Bachmann's Bundle Pacing

ACTIVE COMPARATOR

Standard Clinical BB Pacing

Device: Bachmann's Bundle

Right Atrial Appendage Pacing

ACTIVE COMPARATOR

Standard Clinical RAA Pacing

Device: Right Atrial Appendage Pacing

Interventions

Bachmann's Bundle DEVICE

BBP

Bachmann's Bundle Pacing

Right Atrial Appendage Pacing DEVICE

RAA pacing

Right Atrial Appendage Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Medtronic: collaborator

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Silverstein, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Phalunas, MS BME

CONTACT

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

Heather McDonald, MHA CCRC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 15, 2026
• Study Start: August 19, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)