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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Bachmann's bundle lead placement; Procedure: Right atrial appendage lead placement

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bachmann's bundle area pacing; Lead placement in Bachmann's bundle area	Procedure: Bachmann's bundle lead placement; Atrial lead placement at Bachmann's bundle area
Active Comparator: Right atrial appendage pacing; Lead placement in the right atrial appendage	Procedure: Right atrial appendage lead placement; Atrial lead placement in the right atrial appendage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Atrial lead sensing threshold (millivolts)		Over 15 month follow up
Atrial lead impedance threshold (Ohms)		Over 15 month follow up
Atrial Fibrillation Severity Scale Version 2.0	Change in quality of life. The Atrial Fibrillation Severity Scale (AFSS) is composed of 19 items investigating four domains: AF burden (comprised of AF frequency + AF duration + AF severity): score range is 3-10, higher score = greater burden; Health care utilization: score range is 0-7 for each question, higher score = more utilization; Symptoms: score range is 0-35, higher score = greater symptom severity; Global well-being: score range is 1-10, higher score = better quality of life	Over 15 month follow up
EQ-5D-3L survey (*EQ-5D-3L is the name of the instrument and is not an acronym)	Change in quality of life. The EQ-5D-3L is a standardized instrument to assess generic health-related quality of life and contains questions on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of the five dimension, respondents are offered three response categories (no problems, some problems, extreme problems), leading to 243 possible health states. These health states are then converted into index based values (utilities) ranging from 0 to 1 by applying a valuation algorithm. The EQ-5D instrument includes a visual analogue scale (VAS), on which the patient is asked to score his/her current health state between 0 (worst imaginable health state) and 100 (best imaginable health state).	Over 15 month follow up
Hospitalization or urgent outpatient visit for atrial fibrillation		Within 15 months follow-up post pacemaker
Hospitalization or urgent outpatient visit for heart failure		Within 15 months follow-up post pacemaker
Cerebrovascular accident		Within 15 months follow-up post pacemaker
Atrial Fibrillation Ablation		Within 15 months follow-up post pacemaker
New start or up-titration of medications for the primary diagnosis of atrial fibrillation		Within 15 months follow-up post pacemaker

Collaborators and Investigators

• Sponsor: University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 27, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 00001532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: De-identified data upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No