NCT07874763 · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Bachmann's Bundle Versus Right Atrial Appendage Pacing
(BACH-RAP)
What this study is about
Participants will be randomly assigned to one of two clinical treatment treatment group$1, both of which are standard care procedures performed in the right atrium (RA): treatment group$1 A: Pacing from the Bachmann's Bundle in the right atrium (upper right chamber of the heart) treatment group$1 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.
View original scientific description
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.
Interventions
DEVICE
Bachmann's Bundle Pacing
BB Pacing
DEVICE
Right Atrial Appendage Pacing
RAA Pacing
Primary outcome measures
Cardiac Procedural Outcomes
Time frame: 12 months
The primary endpoint is freedom from cardiac perforation, pericarditis, lead dislodgement, lead revision, and all-cause mortality within 12-months of randomization.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Pittsburgh, Pennsylvania
Collaborators
Medtronic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2026 · Source of record for eligibility and locations