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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05153291
• Other study ID #: 00001532
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Bachmann's bundle lead placement
Atrial lead placement at Bachmann's bundle area
• Right atrial appendage lead placement
Atrial lead placement in the right atrial appendage

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Atrial lead procedure time		At implant
Secondary	Atrial lead fluoroscopy time		At implant
Secondary	Atrial lead complications		Over 15 month follow up
Secondary	Atrial lead capture threshold (Volts)		Over 15 month follow up
Secondary	Atrial lead sensing threshold (millivolts)		Over 15 month follow up
Secondary	Atrial lead impedance threshold (Ohms)		Over 15 month follow up
Secondary	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
Secondary	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
Secondary	Hospitalization or urgent outpatient visit for atrial fibrillation		Within 15 months follow-up post pacemaker
Secondary	Hospitalization or urgent outpatient visit for heart failure		Within 15 months follow-up post pacemaker
Secondary	Cerebrovascular accident		Within 15 months follow-up post pacemaker
Secondary	Atrial Fibrillation Ablation		Within 15 months follow-up post pacemaker
Secondary	New start or up-titration of medications for the primary diagnosis of atrial fibrillation		Within 15 months follow-up post pacemaker