Atrial Synchrony Evaluation of Bachmann Bundle Pacing in Sick Sinus Syndrome

July 3, 2025 updated by: You Wu, Shiyan City Renmin Hospital

Clinical Study on the Application of Two-dimensional Speckle Tracking Imaging to Evaluate the Atrial Synchrony of Bachmann Bundle Pacing in Patients With Sick Sinus Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Beijing AnZhen Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Inter-atrial Electromechanical Delay (Inter AEMD)
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
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)
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
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)
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in P-wave Duration (PWD) and Morphology
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Measured from the 12-lead surface ECG, including P-wave duration (P-AT, P-Am) and P-wave axis (P-aI, P-aL).
Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in QRS Duration and Axis
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Measured from the 12-lead surface ECG.
Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in Left Atrial (LA) and Right Atrial (RA) Dimensions
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Measured by standard 2D echocardiography.
Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in Left Ventricular End-Systolic Diameter (LVESD) and End-Diastolic Diameter (LVEDD)
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Measured by standard 2D echocardiography.
Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in Left Atrial Strain Parameters
Time Frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Includes left atrial reservoir strain (LASr), conduit strain (LAScd), and contraction strain (LASct), measured by 2D-STI.
Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Recurrence of Atrial Arrhythmia
Time Frame: Up to 1 year
Number of patients experiencing newly developed or recurrent atrial fibrillation or atrial tachycardia.
Up to 1 year
Change in Atrial Pacing Threshold
Time Frame: 1 Month Post-procedure, 3 Months Post-procedure
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
1 Month Post-procedure, 3 Months Post-procedure
Change in Atrial Sensing (P-wave amplitude)
Time Frame: 1 Month Post-procedure, 3 Months Post-procedure
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
1 Month Post-procedure, 3 Months Post-procedure
Change in Atrial Pacing Impedance
Time Frame: 1 Month Post-procedure, 3 Months Post-procedure
Measured via pacemaker programmer interrogation. Unit: Ohms (Ω).
1 Month Post-procedure, 3 Months Post-procedure
Change in Ventricular Pacing Threshold
Time Frame: 1 Month Post-procedure, 3 Months Post-procedure
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
1 Month Post-procedure, 3 Months Post-procedure
Change in Ventricular Sensing (R-wave amplitude)
Time Frame: 1 Month Post-procedure, 3 Months Post-procedure
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
1 Month Post-procedure, 3 Months Post-procedure
Change in Ventricular Pacing Impedance
Time Frame: 1 Month Post-procedure, 3 Months Post-procedure
Measured via pacemaker programmer interrogation. Unit: Ohms (Ω).
1 Month Post-procedure, 3 Months Post-procedure
Percentage of Ventricular Pacing
Time Frame: 1 Month Post-procedure, 3 Months Post-procedure
Measured via pacemaker programmer interrogation. Unit: Percentage (%).
1 Month Post-procedure, 3 Months Post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shiyan City Renmin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yongquan Wu, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025126x

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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