NCT07874763Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 334 (estimated)
- First submitted
- 4 Oct 2026
- Start date
- Aug 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Diseases
- Atrial fibrillation
- NCT number
- NCT07874763
What you commit to
- Study type: Interventional
- Planned participants: 334
- From Aug 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CIED implant
- Organ or hematologic transplant, or currently being evaluated for an organ transplant
Other illness
- 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.
Other
- Known pericarditis or pericardial effusion
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.