Sick Sinus SyndromeNCT07055035
Atrial Synchrony Evaluation of Bachmann Bundle Pacing in Sick Sinus Syndrome
A study testing Bachmann Bundle Pacing and Right Atrial Appendage Pacing in people with Sick Sinus Syndrome, run by Shiyan City Renmin Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Sick Sinus Syndrome
- What is being tested?
- Bachmann Bundle Pacing and Right Atrial Appendage Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Shiyan, Hubei, 442000
About this study
Official title: 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.
Read the 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
- Being tested
- Bachmann Bundle Pacing, Right Atrial Appendage Pacing
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bachmann Bundle PacingDevice
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 PacingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Right Atrial Appendage Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Secondary outcomes (13)
Change in P-wave Duration (PWD) and Morphology
Measured from the 12-lead surface ECG, including P-wave duration (P-AT, P-Am) and P-wave axis (P-aI, P-aL).
Measured: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in QRS Duration and Axis
Measured from the 12-lead surface ECG.
Measured: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in Left Atrial (LA) and Right Atrial (RA) Dimensions
Measured by standard 2D echocardiography.
Measured: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in Left Ventricular End-Systolic Diameter (LVESD) and End-Diastolic Diameter (LVEDD)
Measured by standard 2D echocardiography.
Measured: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Change in Left Atrial Strain Parameters
Includes left atrial reservoir strain (LASr), conduit strain (LAScd), and contraction strain (LASct), measured by 2D-STI.
Measured: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Recurrence of Atrial Arrhythmia
Number of patients experiencing newly developed or recurrent atrial fibrillation or atrial tachycardia.
Measured: Up to 1 year
Change in Atrial Pacing Threshold
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
Measured: 1 Month Post-procedure, 3 Months Post-procedure
Change in Atrial Sensing (P-wave amplitude)
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
Measured: 1 Month Post-procedure, 3 Months Post-procedure
Change in Atrial Pacing Impedance
Measured via pacemaker programmer interrogation. Unit: Ohms (Ω).
Measured: 1 Month Post-procedure, 3 Months Post-procedure
Change in Ventricular Pacing Threshold
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
Measured: 1 Month Post-procedure, 3 Months Post-procedure
Change in Ventricular Sensing (R-wave amplitude)
Measured via pacemaker programmer interrogation. Unit: millivolts (mV).
Measured: 1 Month Post-procedure, 3 Months Post-procedure
Change in Ventricular Pacing Impedance
Measured via pacemaker programmer interrogation. Unit: Ohms (Ω).
Measured: 1 Month Post-procedure, 3 Months Post-procedure
Percentage of Ventricular Pacing
Measured via pacemaker programmer interrogation. Unit: Percentage (%).
Measured: 1 Month Post-procedure, 3 Months Post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jan 2023
- Primary completion30 Apr 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyan City Renmin Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, You Wu, Beijing Anzhen Hospital
- Investigators
- Yongquan Wu, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055035
- Sponsor's protocol ID
- 2025126x
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07055035
- Acronym / sponsor ID
- 2025126x
- Conditions
- Sick Sinus Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shiyan City Renmin HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bachmann Bundle Pacing (BBP) Group | Experimental | Device: Bachmann Bundle PacingPatients 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. |
| Right Atrial Appendage (RAA) Pacing Group | Active comparator | Device: Right Atrial Appendage PacingPatients 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bachmann Bundle PacingImplantation 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. | Device | Bachmann Bundle Pacing (BBP) Group |
| Right Atrial Appendage PacingImplantation 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. | Device | Right Atrial Appendage (RAA) Pacing Group |
Primary outcome
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.
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.
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.
13 secondary outcomes
Change in P-wave Duration (PWD) and Morphology
Time frame: 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
Change in Left Atrial (LA) and Right Atrial (RA) Dimensions
Time frame: 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
Change in Left Atrial Strain Parameters
Time frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Recurrence of Atrial Arrhythmia
Time frame: Up to 1 year
Change in Atrial Pacing Threshold
Time frame: 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
Change in Atrial Pacing Impedance
Time frame: 1 Month Post-procedure, 3 Months Post-procedure
Change in Ventricular Pacing Threshold
Time frame: 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
Change in Ventricular Pacing Impedance
Time frame: 1 Month Post-procedure, 3 Months Post-procedure
Percentage of Ventricular Pacing
Time frame: 1 Month Post-procedure, 3 Months Post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongquan Wu principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bachmann Bundle Pacing and Right Atrial Appendage Pacing in people with Sick Sinus Syndrome, run by Shiyan City Renmin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inter-atrial Electromechanical Delay (Inter AEMD) (time frame: Baseline, 1 Month Post-procedure, 3 Months Post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.