ECG and Echo Characteristics of BBAP (BBAP-ECG/echo)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Pacing Therapy; Cardiac Pacing

Treatments: Procedure: BBAP and RAA pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT06995027

BBAP-ECG/echo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm - BBAP and RAA pacing

Experimental group

Description:

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.

Treatment:

Procedure: BBAP and RAA pacing