Atrial Synchrony Evaluation of Bachmann Bundle Pacing in Sick Sinus Syndrome

NCT07055035 | Completed

• 1 other identifier: 2025126x
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Sick Sinus Syndrome

Outcome Measures

Primary Outcomes (3)

• Change in Inter-atrial Electromechanical Delay (Inter AEMD)

  Measured by two-dimensional speckle tracking imaging (2D-STI) as the time difference between the onset of the P-wave on the electrocardiogram (ECG) and the peak longitudinal strain of the lateral walls of the right and left atria. A smaller value indicates better inter-atrial synchrony.

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

• Change in Intra-atrial Mechanical Delay (IAMD)

  Measured by 2D-STI as the standard deviation of the time-to-peak longitudinal strain of six segments of the left atrium. A smaller value indicates better intra-atrial synchrony.

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

• Change in Intra-right Atrial Electromechanical Delay (Intra-right AEMD)

  Measured by 2D-STI as the time difference between the earliest and latest peak longitudinal strain within the right atrium segments.

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

Secondary Outcomes (13)

• Change in P-wave Duration (PWD) and Morphology

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

• Change in QRS Duration and Axis

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

• Change in Left Atrial (LA) and Right Atrial (RA) Dimensions

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

• Change in Left Ventricular End-Systolic Diameter (LVESD) and End-Diastolic Diameter (LVEDD)

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

• Change in Left Atrial Strain Parameters

  Baseline, 1 Month Post-procedure, 3 Months Post-procedure

Study Arms (2)

Bachmann Bundle Pacing (BBP) Group

EXPERIMENTAL

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.

Device: Bachmann Bundle Pacing

Right Atrial Appendage (RAA) Pacing Group

ACTIVE COMPARATOR

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.

Device: Right Atrial Appendage Pacing

Interventions

Bachmann Bundle Pacing 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.

Bachmann Bundle Pacing (BBP) Group

Right Atrial Appendage Pacing 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.

Right Atrial Appendage (RAA) Pacing Group

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyan City Renmin Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Shiyan, Hubei, 442000, China

Location

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongquan Wu

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 8, 2025
• Study Start: January 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: January 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

CN (1)