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Completed

NCT Number: NCT06995027

ECG and Echo Characteristics of BBAP

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BBAP and RAA pacing

Procedure

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.

Primary outcomes

  1. 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

  2. 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

  3. Atrial-paced P-onset to A-wave initiation time under Doppler at mitral and tricuspid valves at implantation

    Time frame: Perioperative

Secondary outcomes

  1. LAD from echocardiographic measurements before implantation and during regular follow-ups

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

Sponsors and collaborators

Lead sponsor

Shanghai Tong Ren Hospital

Other

Registry information

Official study title

Electrocardiographic and Echocardiographic Characteristics of Bachmann's Bundle Area Pacing

Acronym: BBAP-ECG/echo

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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