Electrocardiographic and Echocardiographic Characteristics of Bachmann's Bundle Area Pacing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
Study Overview
Brief Summary
This is a prospective, single-site, non-randomized, interventional study. The purpose is to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and computed tomography (CT) images (optional) during Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
Detailed Description
Bachmann's bundle (BB) has emerged as an alternative pacing location to conventional right atrial appendage (RAA) pacing and is expected to avoid the interatrial conduction delay (IACD) and atrial dyssynchrony induced by RAA pacing. A recent study reported in patients with atrial pacing indications and baseline IACD that decreased atrial arrhythmia burden, recurrence, and de novo incidence were found in BB pacing, compared with right atrial septal pacing and RAA pacing. This study aimed to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and CT images during BB area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) during regular pacemaker implantation procedures. The purpose is to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged >= 18 years old
- •Patients who are willing to provide Informed Consent
- •Patients who are indicated to atrial pacing, dual-chamber pacing, or cardiac resynchronization therapy
- •Patients who consent to Bachmann's bundle area pacing
Exclusion Criteria
- •Patients who are indicated for cardiac implantable electronic device replacement or upgrade
- •Patients with defibrillation indications
- •Patients who are pregnant or have a plan for pregnancy during the study
- •Patients who have medical conditions that would limit study participation
- •Patients who were already enrolled in other trials which would impact his/her participation
Arms & Interventions
Single Arm - BBAP and RAA pacing
Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings. BBAP will be kept with remaining implantation procedure and followed-up at 3 months and/or 6 months.
Intervention: BBAP and RAA pacing (Procedure)
Outcomes
Primary Outcomes
Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
Time Frame: From implantation to regular follow-ups up to 6 months
Atrial-paced ECG P-wave amplitude at implantation and during regular follow-ups
Time Frame: From implantation to regular follow-ups up to 6 months
Atrial-paced P-onset to A-wave initiation time under Doppler at mitral and tricuspid valves at implantation
Time Frame: Perioperative
Secondary Outcomes
- LAD from echocardiographic measurements before implantation and during regular follow-ups(Baseline before implantation to regular follow-ups up to 6 months)