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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bachmann's bundle area pacing

Lead placement in Bachmann's bundle area

Group Type EXPERIMENTAL

Bachmann's bundle lead placement

Intervention Type PROCEDURE

Atrial lead placement at Bachmann's bundle area

Right atrial appendage pacing

Lead placement in the right atrial appendage

Group Type ACTIVE_COMPARATOR

Right atrial appendage lead placement

Intervention Type PROCEDURE

Atrial lead placement in the right atrial appendage

Interventions

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Bachmann's bundle lead placement

Atrial lead placement at Bachmann's bundle area

Intervention Type PROCEDURE

Right atrial appendage lead placement

Atrial lead placement in the right atrial appendage

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No