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

NCT05153291 | Unknown

• 1 other identifier: 00001532
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial arrhythmia burden from pacemaker counters

  Derived from pacemaker counters and expressed as the average percentage of time per day in atrial fibrillation/tachycardia.

  Over 15 month follow up

Secondary Outcomes (14)

• Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups

  At implant

• Atrial lead procedure time

  At implant

• Atrial lead fluoroscopy time

  At implant

• Atrial lead complications

  Over 15 month follow up

• Atrial lead capture threshold (Volts)

  Over 15 month follow up

Study Arms (2)

Bachmann's bundle area pacing

EXPERIMENTAL

Lead placement in Bachmann's bundle area

Procedure: Bachmann's bundle lead placement

Right atrial appendage pacing

ACTIVE COMPARATOR

Lead placement in the right atrial appendage

Procedure: Right atrial appendage lead placement

Interventions

Bachmann's bundle lead placement PROCEDURE

Atrial lead placement at Bachmann's bundle area

Bachmann's bundle area pacing

Right atrial appendage lead placement PROCEDURE

Atrial lead placement in the right atrial appendage

Right atrial appendage pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Electrophysiology Fellow

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 10, 2021
• Study Start: May 28, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)