Bachmann's Bundle Pacing for Atrial Fibrillation

Overseen By Margaret Infeld, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Disqualifiers: Permanent atrial fibrillation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new method of placing pacemaker leads in the heart can reduce irregular heartbeats. Researchers are comparing two methods: placing the lead in Bachmann's bundle and the standard method in the right atrial appendage. The study targets individuals who need a pacemaker and experience issues like occasional atrial fibrillation or a delay in atrial communication. Participants will have their pacemaker leads placed using one of these methods and will be monitored for 15 months to assess effectiveness. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance future pacemaker procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these atrial lead placements are safe?

Research has shown that placing a pacemaker lead in Bachmann's bundle is safe for patients. One study found this method to be a safe alternative to the usual practice of placing the lead in the right atrial appendage. Specifically, the study reported success in 72% of patients, indicating that this method is generally well-tolerated and does not cause major complications.

Additionally, using leadless pacemakers targeting Bachmann's bundle has lowered the risk of infections and problems with the leads. This means the treatment not only works but also helps avoid some issues seen with traditional pacemakers. Overall, the findings suggest that Bachmann's bundle pacing is a safe option for patients who need a pacemaker. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring Bachmann's bundle pacing because it offers a potentially new way to manage heart rhythm disorders. Unlike traditional pacing strategies, which typically involve lead placement in the right atrial appendage, this method targets the Bachmann's bundle area, a key structure involved in the electrical conduction of the heart. This could lead to more effective synchronization of atrial contractions, potentially reducing arrhythmias. By focusing on this specific area, the technique might provide antiarrhythmic benefits that current treatments don’t fully address, representing a significant step forward in cardiac care.

What evidence suggests that this trial's treatments could be effective for atrial pacing?

This trial will compare two pacing methods: Bachmann's bundle area pacing and right atrial appendage pacing. Research suggests that pacing Bachmann's bundle may prevent irregular heartbeats by improving the synchronization of the heart's upper chambers. Studies have shown that this area is crucial for the electrical signals that help the upper chambers work in sync. Mapping to guide the placement of pacing devices has successfully enhanced upper chamber function. In one study, this pacing method succeeded in 72% of patients, indicating its potential usefulness. Although more data is needed, early results are promising for reducing irregular heartbeats. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is referred for permanent pacemaker implantation with an indication for an atrial lead

Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration >120ms on a 12-lead ECG)

Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires

Exclusion Criteria

Subject has left ventricular ejection fraction <45%

Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)

Subject has pacemaker implantation prior to planned atrioventricular nodal ablation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either electrically-guided Bachmann's bundle lead placement or right atrial appendage lead placement

15 months

Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for atrial arrhythmia burden and quality of life changes

15 months

What Are the Treatments Tested in This Trial?

Interventions

• Atrial lead position
• Bachmann's bundle lead placement
• Right atrial appendage lead placement

How Is the Trial Designed?

Group I: Bachmann's bundle area pacing Experimental Treatment 1 Intervention

Lead placement in Bachmann's bundle area

Group II: Right atrial appendage pacing Active Control 1 Intervention

Lead placement in the right atrial appendage

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666084925008642

Leadless Atrial Pacing Targeting Bachmann's Bundle for ... This case demonstrates the first-in-human permanent implantation of a leadless pacemaker in the BB area, providing a strategy for leadless atrial ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10105863/

Mapping-guided atrial lead placement determines optimal ... Bachmann's bundle is the preferential route for inter-atrial conduction during normal SR. It stretches sub-epicardially across the inter-atrial ...

3. heartrhythmopen.com heartrhythmopen.com/article/S2666-5018(24)00414-8/fulltext

A novel atrial pacing modality with efficient anatomical ... This case report describes 2 cases of dual-chamber pacing in which Bachmann's bundle was initially targeted, but both ultimately resulted in ...

4. academic.oup.com academic.oup.com/europace/article/27/Supplement_1/euaf085.539/8141691

A novel approach for Bachmann's bundle pacing implantation ... Clinical impact of Bachmann's bundle pacing defined by electrocardiographic criteria on atrial arrhythmia outcomes · Atrial lead placement ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824000977

Short-term safety and feasibility of a practical approach to ... Bachmann pacing was achieved in 72% of patients with atrial lead placement in the high right atrial septum. ▫. Routine placement of pacing leads in the high ...

6. jacc.org jacc.org/doi/10.1016/j.jaccas.2025.104083

Leadless Atrial Pacing Targeting Bachmann's Bundle for ... Leadless pacemakers have transformed pacing by reducing risk for infection and lead-related complications. The feasibility of achieving leadless ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04749836

Outcomes and Safety of Various Conduction System ... Implant success rate, specific implant characteristics, procedural complications, electrical parameters and clinical outcomes will be analyzed at implantation, ...

8. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02709-2/abstract

Accelerated Bachmann bundle area pacing for atrial ... Accelerated BBAP was found to reduce the NT-proBNP and was accompanied by an improvement in the diastolic function and exercise capacity.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5079114/

A simple method for Bachmann's bundle pacing with ... Most of the studies have shown beneficial results of BB pacing in terms of atrial fibrillation incidence and recurrence in patients with sinus node dysfunction.