ECG and Echo Characteristics of BBAP

NCT06995027 | Recruiting

• 1 other identifier: BBAP-ECG/echo
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacing Therapy; Cardiac Pacing

Keywords

Bachmann's bundle pacing; Bradycardia; Physiological pacing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  Baseline before implantation to regular follow-ups up to 6 months

Study Arms (1)

Single Arm - BBAP and RAA pacing

EXPERIMENTAL

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.

Procedure: BBAP and RAA pacing

Interventions

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.

Single Arm - BBAP and RAA pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (1)

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

• Qiu Z, Xianhao W, Hu W, Tang Y, Xu Z, Ou Z, Zhou Y, Ren Z, Shi T, Lu H. Interatrial Synchronized Pacing at the Posterosuperior Bundle: Feasibility, Mechanism, and Mid-Term Outcomes. Circ Arrhythm Electrophysiol. 2025 Dec 25:e014357. doi: 10.1161/CIRCEP.125.014357. Online ahead of print.

  PMID: 41446938 DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhaohui Qiu, MD, PhD

CONTACT

+862152039999; qzh3503@shtrhospital.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 29, 2025
• Study Start: August 31, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)