Atrial Fibrillation (AF)BACH-RAPNCT07874763
Bachmann's Bundle Versus Right Atrial Appendage Pacing
A study testing Bachmann's Bundle Pacing and Right Atrial Appendage Pacing in people with Atrial Fibrillation (AF), run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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 (BB) in the right atrium (upper right chamber of the heart) Arm B: Pacing from the right atrial appendage (RAA - a sac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Bachmann's Bundle Pacing and Right Atrial Appendage Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Heather McDonald, MHA CCRC, 412-513-5321, heather.mcdonald@ahn.org
Heather McDonald, MHA CCRC, heather.mcdonald@ahn.org
About this study
Official title: BACHmann Bundle Versus Right Atrial Appendage Pacing Randomized Controlled Trial: Learning Curve, Safety, Efficacy, Physiological Effect, and Transthoracic Echo Guidance
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.
Read the detailed description
Patients requiring cardiac resynchronization therapy (CRT) will screened for the study prior to any research procedures. Once consent has been granted, participants will be randomly assigned to Arm A (BB pacing) or Arm B (RAA pacing). After the procedure, they will have post-implantation visits at 3, 6, and 12 months.
The purpose of the study is to compare the safety of Bachmann bundle versus right atrial appendage lead placement to reduce the incidence of the composite outcome of cardiac perforation, pericarditis, lead dislodgement, pericardial effusion, lead revision, and all-cause mortality within 12-month of follow-up
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Bachmann's Bundle Pacing, Right Atrial Appendage Pacing
- Keywords
- Atrial Pacing, Atrial Fibrillation, AF, Cardiac Resynchronization Therapy, CRT
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bachmann's Bundle PacingDevice
BB Pacing
Right Atrial Appendage PacingDevice
RAA Pacing
| Study group | Role | What they receive |
|---|---|---|
| Bachmann's Bundle Pacing | Active comparator | Standard Clinical BB Pacing Receives: Device: Bachmann's Bundle Pacing |
| Right Atrial Appendage Pacing | Active comparator | Standard Clinical RAA Pacing Receives: Device: Right Atrial Appendage Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Acute Success
Acute success (fluoroscopy vs electrogram method) (Binary: yes/no)
Measured: 24 hours
P-wave function
Change in P-wave duration (milliseconds)
Measured: 24 hours
Atrial fibrillation (AF)/atrial flutter (AFl) progression
Incidence of AF/ AFl progression (percentage)
Measured: 12 months
Fluoroscopy time
Procedure and total fluoroscopy time (min/s)
Measured: 24 hours
Lead positions
Number of lead positions attempted (whole number)
Measured: 24 hours
Atrial pacing
Percentage atrial pacing (percentage)
Measured: 12 months
Adverse events (AEs)
AEs (e.g. pocket revisions and hematomas) (whole number)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start19 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Josh Silverstein, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Joshua Silverstein, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874763
- Sponsor's protocol ID
- 2025-180
- Acronym
- BACH-RAP
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will share aggregated data with any potential collaborators who may join the study. We will not share individual data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BACHmann Bundle Versus Right Atrial Appendage Pacing Randomized Controlled Trial: Learning Curve, Safety, Efficacy, Physiological Effect, and Transthoracic Echo Guidance
- ClinicalTrials.gov ID
- NCT07874763
- Acronym / sponsor ID
- BACH-RAP / 2025-180
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Pacing, Atrial Fibrillation, AF, Cardiac Resynchronization Therapy, CRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- Medtronic
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients requiring cardiac resynchronization therapy (CRT) will screened for the study prior to any research procedures. Once consent has been granted, participants will be randomly assigned to Arm A (BB pacing) or Arm B (RAA pacing). After the procedure, they will have post-implantation visits at 3, 6, and 12 months.
The purpose of the study is to compare the safety of Bachmann bundle versus right atrial appendage lead placement to reduce the incidence of the composite outcome of cardiac perforation, pericarditis, lead dislodgement, pericardial effusion, lead revision, and all-cause mortality within 12-month of follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bachmann's Bundle Pacing | Active comparator | Device: Bachmann's Bundle PacingStandard Clinical BB Pacing |
| Right Atrial Appendage Pacing | Active comparator | Device: Right Atrial Appendage PacingStandard Clinical RAA Pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bachmann's Bundle PacingBB Pacing | Device | Bachmann's Bundle Pacing |
| Right Atrial Appendage PacingRAA Pacing | Device | Right Atrial Appendage Pacing |
Primary outcome
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.
7 secondary outcomes
Acute Success
Time frame: 24 hours
P-wave function
Time frame: 24 hours
Atrial fibrillation (AF)/atrial flutter (AFl) progression
Time frame: 12 months
Fluoroscopy time
Time frame: 24 hours
Lead positions
Time frame: 24 hours
Atrial pacing
Time frame: 12 months
Adverse events (AEs)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. We will share aggregated data with any potential collaborators who may join the study. We will not share individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Silverstein, MD principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bachmann's Bundle Pacing and Right Atrial Appendage Pacing in people with Atrial Fibrillation (AF), run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin Phalunas, MS BME (412-359-3747, caitlin.phalunas@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Procedural Outcomes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.