Atrial Synchrony Evaluation of Bachmann Bundle Pacing in Sick Sinus Syndrome

NCT ID: NCT07055035

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-01-31

Brief Summary

This is a prospective, randomized study to compare the effects of Bachmann bundle pacing (BBP) versus conventional right atrial appendage (RAA) pacing on atrial electromechanical synchrony in patients with sick sinus syndrome (SSS). The study utilizes two-dimensional speckle tracking imaging (2D-STI) to assess improvements in cardiac function and synchrony, aiming to determine a more optimal pacing site for SSS patients.

Detailed Description

Sick sinus syndrome (SSS) is a common indication for permanent pacemaker implantation. Conventional right atrial appendage (RAA) pacing, however, is non-physiological and may lead to atrial conduction delays, atrial remodeling, and an increased risk of atrial fibrillation. Bachmann bundle pacing (BBP) is emerging as a more physiological pacing strategy that may correct atrial conduction delays and improve electromechanical synchronization. This study prospectively enrolled and randomized 72 patients with SSS to receive either BBP or RAA pacing. The primary objective is to evaluate the differences in atrial synchrony, cardiac function, and pacing parameters between the two groups at baseline, 1-month, and 3-month follow-ups, using electrocardiography and two-dimensional speckle tracking imaging (2D-STI). The study aims to provide evidence for BBP as a superior treatment option for improving long-term outcomes in SSS patients.

Conditions

Sick Sinus Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bachmann Bundle Pacing (BBP) Group

Patients were randomized to receive a permanent pacemaker with the atrial lead placed in the Bachmann bundle region. They were followed up at 1 month and 3 months post-procedure.

Group Type: EXPERIMENTAL

Bachmann Bundle Pacing

Intervention Type: DEVICE

Implantation of a permanent pacemaker system. The atrial lead (Medtronic 3830 active electrode) is surgically positioned and fixed in the Bachmann bundle region, located at the angle between the superior vena cava and the atrium in the mid-posterior position of the high atrial septum. Successful placement is confirmed by achieving a P-wave width shortening of at least 30ms compared to the preoperative P-wave. The ventricular lead is positioned in the mid-to-lower portion of the ventricular septum. Pacing parameters are measured and confirmed to be good.

Right Atrial Appendage (RAA) Pacing Group

Patients were randomized to receive a permanent pacemaker with the atrial lead placed in the conventional right atrial appendage. They were followed up at 1 month and 3 months post-procedure.

Group Type: ACTIVE_COMPARATOR

Right Atrial Appendage Pacing

Intervention Type: DEVICE

Implantation of a permanent pacemaker system using the conventional technique. The atrial active electrode is surgically positioned and fixed in the right atrial appendage. The ventricular lead is placed in the mid-to-lower portion of the ventricular septum. Pacing parameters (sensing \> 2.0mV; impedance between 300 to 1000Ω; threshold \< 1.5mV) are confirmed to be good.

Interventions

Bachmann Bundle Pacing

Implantation of a permanent pacemaker system. The atrial lead (Medtronic 3830 active electrode) is surgically positioned and fixed in the Bachmann bundle region, located at the angle between the superior vena cava and the atrium in the mid-posterior position of the high atrial septum. Successful placement is confirmed by achieving a P-wave width shortening of at least 30ms compared to the preoperative P-wave. The ventricular lead is positioned in the mid-to-lower portion of the ventricular septum. Pacing parameters are measured and confirmed to be good.

Intervention Type: DEVICE

Right Atrial Appendage Pacing

Implantation of a permanent pacemaker system using the conventional technique. The atrial active electrode is surgically positioned and fixed in the right atrial appendage. The ventricular lead is placed in the mid-to-lower portion of the ventricular septum. Pacing parameters (sensing \> 2.0mV; impedance between 300 to 1000Ω; threshold \< 1.5mV) are confirmed to be good.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Meets diagnostic criteria for sick sinus syndrome (e.g., persistent sinus bradycardia <50 bpm, sinus arrest, sinoatrial block, or tachy-brady syndrome).
• Age between 30 and 90 years.
• Has not taken any other antiarrhythmic drugs within one month prior to enrollment.
• Has not participated in any other related clinical trials.
• Voluntarily signs the informed consent form.

Exclusion Criteria

• Patients with severe primary diseases causing unstable vital signs (e.g., severe circulatory, digestive, or neurological system diseases).
• Patients with a history of recurrent syncope, Adams-Stokes syndrome, severe bradycardia (lowest sinus rhythm <30 bpm), or long RR interval >3s.
• Pregnant or lactating women.
• Patients with mental illness.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiyan City Renmin Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

You Wu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongquan Wu

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital, Capital Medical University

Shiyan, Hubei, China

Countries

China

Other Identifiers

2025126x

Identifier Type: -

Identifier Source: org_study_id