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

University of Vermont

Status

Unknown

Conditions

Atrial Fibrillation

Treatments

Procedure: Bachmann's bundle lead placement

Procedure: Right atrial appendage lead placement

Study type

Interventional

Funder types

Other

Identifiers

NCT05153291

00001532

Details and patient eligibility

About

Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is >18 years old
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 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
Subject has resting spontaneous sinus rate >85 beats-per-minute
Subject has left ventricular ejection fraction <45%
Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
Subject is currently enrolled in a potentially confounding trial
Subject is pregnant
Subject's anticipated life expectancy is less than 1 year