ECG and Echo Characteristics of BBAP

Not Applicable

Recruiting

• Conditions: Pacing Therapy; Cardiac Pacing

• Registration Number: NCT06995027
• Lead Sponsor: Shanghai Tong Ren Hospital

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 Timeline

• Study Start: 2024-08-31
• Study First Submitted: 2025-04-23
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Atrial-paced ECG P-wave duration at implantation and during regular follow-ups	From implantation to regular follow-ups up to 6 months
Atrial-paced ECG P-wave amplitude at implantation and during regular follow-ups	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	Perioperative

Secondary Outcome Measures

Name	Time	Method
LAD from echocardiographic measurements before implantation and during regular follow-ups	Baseline before implantation to regular follow-ups up to 6 months

Trial Locations

Locations (1)

Shanghai Tong Ren Hospital; 🇨🇳 Shanghai, Shanghai, China