Clinical trial NCT06995027: ECG and Echo Characteristics of BBAP
Official title: Electrocardiographic and Echocardiographic Characteristics of Bachmann's Bundle Area Pacing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pacing Therapy
Cardiac Pacing
Keywords: Bachmann&#39;s bundle pacing
Bradycardia
Physiological pacing
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
timeFrame: From implantation to regular follow-ups up to 6 months
measure: Atrial-paced ECG P-wave amplitude at implantation and during regular follow-ups
timeFrame: From implantation to regular follow-ups up to 6 months
measure: Atrial-paced P-onset to A-wave initiation time under Doppler at mitral and tricuspid valves at implantation
timeFrame: Perioperative
Secondary outcomes:
measure: LAD from echocardiographic measurements before implantation and during regular follow-ups
timeFrame: Baseline before implantation to regular follow-ups up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tong Ren Hospital
state: Shanghai
Study officials:
References: