Clinical trial NCT05153291: Electrically Guided Bachmann's Bundle Pacing: A Lead Placement Strategy With Potential Antiarrhythmic Benefits
Official title: Electrically Guided Bachmann's Bundle Pacing Pilot Study: A Novel Lead Placement Strategy With Potential Antiarrhythmic Benefits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Atrial arrhythmia burden from pacemaker counters
timeFrame: Over 15 month follow up
Secondary outcomes:
measure: Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups
timeFrame: At implant
measure: Atrial lead procedure time
timeFrame: At implant
measure: Atrial lead fluoroscopy time
timeFrame: At implant
measure: Atrial lead complications
timeFrame: Over 15 month follow up
measure: Atrial lead capture threshold (Volts)
timeFrame: Over 15 month follow up
measure: Atrial lead sensing threshold (millivolts)
timeFrame: Over 15 month follow up
measure: Atrial lead impedance threshold (Ohms)
timeFrame: Over 15 month follow up
measure: Atrial Fibrillation Severity Scale Version 2.0
timeFrame: Over 15 month follow up
measure: EQ-5D-3L survey (*EQ-5D-3L is the name of the instrument and is not an acronym)
timeFrame: Over 15 month follow up
measure: Hospitalization or urgent outpatient visit for atrial fibrillation
timeFrame: Within 15 months follow-up post pacemaker
measure: Hospitalization or urgent outpatient visit for heart failure
timeFrame: Within 15 months follow-up post pacemaker
measure: Cerebrovascular accident
timeFrame: Within 15 months follow-up post pacemaker
measure: Atrial Fibrillation Ablation
timeFrame: Within 15 months follow-up post pacemaker
measure: New start or up-titration of medications for the primary diagnosis of atrial fibrillation
timeFrame: Within 15 months follow-up post pacemaker
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References: