Bachmann’s Bundle Pacing vs Right Atrial Appendage Pacing for AF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants needing a new cardiac implantable device with an atrial lead are randomly assigned to pace from Bachmann’s bundle or from the right atrial appendage. Both approaches are standard care and performed in the right atrium, with follow-up visits at 3, 6, and 12 months. The study collects medical records, blood samples, and patient surveys to compare safety outcomes such as perforation, infection, lead problems, effusion, lead revision, and mortality. The trial uses Medtronic devices at a single site and monitors outcomes over one year to determine if one pacing strategy offers a safety advantage. This is not testing a new drug or device; it compares two established techniques in a controlled setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Allegheny General Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Joshua Silverstein, MD — Allegheny Health Network
• Study coordinator: Caitlin Phalunas, MS BME
• Email: caitlin.phalunas@ahn.org
• Phone: 412-359-3747

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.