Electrically Guided Bachmann's Bundle Pacing: A Lead Placement Strategy With Potential Antiarrhythmic Benefits

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

80 Participants Needed

Trial Summary

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.

How does Bachmann's bundle pacing differ from other treatments for atrial fibrillation?

Bachmann's bundle pacing is unique because it closely mimics the heart's natural electrical activity, potentially reducing the risk of atrial fibrillation and improving heart function compared to traditional right atrial appendage pacing. This method helps synchronize the heart's electrical signals, which can prevent the negative effects associated with conventional pacing methods. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new way to place pacemaker leads in the heart to help patients with irregular heartbeats. The leads are placed using both X-ray and electrical signals to ensure they are in the best spot. The goal is to see if this method works better than the usual way of placing leads.

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Prevention of chronic atrial fibrillation by pacing in the region of Bachmann's bundle: results of a multicenter randomized trial. [2019]

2. India pubmed.ncbi.nlm.nih.gov

A simple method for Bachmann's bundle pacing with indigenous modification of J-stylet. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

[Bachmann bundle pacing]. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Alternative atrial pacing site to improve cardiac function: focus on Bachmann's bundle pacing. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Is Bachmann's Bundle the only right site for single-site pacing to prevent atrial fibrillation? Results of a multicenter randomized trial. [2007]