ECG and Echo Characteristics of BBAP

Shanghai Tong Ren Hospital30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pacing Therapy Cardiac Pacing

Interventions

BBAP and RAA pacingPROCEDURE

Bachmann's bundle area pacing and conventional pacing in the right atrial appendage during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

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

Time frame: Baseline before implantation to regular follow-ups up to 6 months

Central Contacts

Zhaohui Qiu, MD, PhD

CONTACT

+862152039999 qzh3503@shtrhospital.com

Data from ClinicalTrials.gov

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