Atrial Synchrony Evaluation of Bachmann Bundle Pacing in Sick Sinus Syndrome

Shiyan City Renmin Hospital

Status: Completed

Conditions: Sick Sinus Syndrome

Treatments: Device: Right Atrial Appendage Pacing; Device: Bachmann Bundle Pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT07055035

2025126x

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Bachmann Bundle Pacing (BBP) Group

Experimental group

Description:

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.

Treatment:

Device: Bachmann Bundle Pacing

Right Atrial Appendage (RAA) Pacing Group

Active Comparator group

Description:

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.

Treatment:

Device: Right Atrial Appendage Pacing