Pacing TherapyPSB-AFNCT07645066
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
A study testing RAA pacing and PSB pacing in people with Pacing Therapy and Cardiac Pacing, run by Shanghai Tong Ren Hospital at 10 sites in China.
Trial summary
This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacing Therapy, Cardiac Pacing
- What is being tested?
- RAA pacing and PSB pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesChina
- Study dates
- 25 Aug 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Indication for permanent pacemaker implantation, including:
- Sinus node dysfunction, defined as at least one of the following:
- Symptomatic sinus bradycardia
- Tachy-brady syndrome
- Chronotropic incompetence
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- Sinus pause / arrest
- Atrioventricular block (if present); if ventricular pacing is required, left bundle branch area pacing is planned
- Expected survival >1 year
- Panned implantation of a device capable of detecting atrial high-rate episodes
- Willing and able to provide informed consent
Who cannot join
- Persistent atrial fibrillation (AF) (>7 days), long-standing persistent AF, permanent AF, or prior atrioventricular node ablation
- Prior cardiac implantable electronic device (CIED) requiring replacement, upgrade, or revision
- Indication for cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT-D)
- Prior cardiac surgery, severe hepatic or renal dysfunction, or other life-threatening systemic diseases
- Acute myocardial infarction within 3 months before enrollment
- Persistent left superior vena cava or dextrocardia
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- Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception
- Participation in another clinical trial that may interfere
- Any condition that, in the opinion of the investigator, makes participation unsuitable
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
China Medical University affiliated AnQing Municipal Hospital
Anqing, Anhui
Liangchuan Chen, +86 13956556381, aqslyy@163.com
- Recruiting
Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Zhaohui Qiu, +862152039999, qzh3503@shtrhospital.com
- Not yet recruiting
Fudan University affiliated Huadong Hospital
Shanghai, Shanghai Municipality
Zhengqi Kong, +86 13816620347, huadongtexu@163.com
- Not yet recruiting
Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality
Zongqi Zhang, +86 18049827281, zqzhang_scdc@126.com
- Not yet recruiting
Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Yisheng Pan, +86 13817273883, shlygjyl@163.com
- Not yet recruiting
Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital
Shanghai, Shanghai Municipality
Zongjun Liu, +86 19821577439, lzj72@126.com
- Not yet recruiting
Tongji University School of Medicine affiliated Tongji University
Shanghai, Shanghai Municipality
Bing Sun, +86 13918324334, woowoocncn@163.com
- Not yet recruiting
Tongling People's Hospital
Tongling, Anhui
Ying Zhang, +86 18005669636, tlph@mail.wh.ah.cn
- Not yet recruiting
Wuhan Asia General Hospital
Wuhan, Hubei
Hongwei Han, +86 15327298622, wuhanagh@163.com
- Not yet recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou
Xianping Long, +86 13885294999, longxianping1201@163.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial Evaluating the Effect of Posterosuperior Bundle Pacing on Atrial Fibrillation Prevention in Patients With Sinus Node Dysfunction
This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation. Approximately 300 patients will be enrolled and randomized to receive atrial pacing at either the PSB region or the right atrial appendage (RAA). The primary endpoint is the occurrence of AF episodes lasting ≥6 minutes, as detected by device or surface electrocardiogram. Patients will be followed for up to 24 months.
Read the detailed description
Sinus node dysfunction (SND) is a common indication for permanent pacemaker implantation. Conventional right atrial appendage (RAA) pacing may result in delayed or dyssynchronous atrial activation, potentially increasing the risk of atrial arrhythmias. Posterosuperior bundle (PSB) pacing is a novel physiological atrial pacing approach. This study is a prospective, multicenter, open-label, randomized controlled trial. A total of approximately 300 eligible SND patients indicated for pacemaker implantation will be enrolled and randomly assigned (1:1) to PSB pacing or RAA pacing. Ventricular pacing will be performed using left bundle branch area pacing in both groups. Following implantation, the pacemaker will be programmed in DDD mode with a lower rate of 70 beats/min during daytime and 60 beats/min during nighttime. Rate-responsive pacing will be enabled by default when available; ATP will be disabled by default. Participants will be followed at 3, 6, 12, and 24 months after implantation. The primary endpoint is the occurrence of AF episodes lasting ≥6 minutes. Secondary endpoints include atrial high-rate episodes, AF burden, pacing parameters, ECG and echocardiographic indices, laboratory findings, and mortality outcomes. Safety endpoints include procedural complications and device-related adverse events.
- Conditions
- Pacing Therapy, Cardiac Pacing
- Being tested
- RAA pacing, PSB pacing
- Keywords
- Posterosuperior bundle pacing, Right atrial appendage pacing, Physiological pacing, atrial pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAA pacingProcedure or surgery
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
PSB pacingProcedure or surgery
Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
| Study group | Role | What they receive |
|---|---|---|
| PSB pacing | Experimental | Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures. Receives: Procedure: PSB pacing |
| RAA pacing | Active comparator | Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures. Receives: Procedure: RAA pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation
Incidence of atrial fibrillation ≥ 6 minutes during follow-ups
Measured: From implantation to regular follow-ups up to 24 months
Secondary outcomes (16)
Atrial high-rate episodes
Measured: From implantation to regular follow-ups up to 24 months
AF burden
Measured: From implantation to regular follow-ups up to 24 months
Intrinsic P-wave duration
Measured from the onset of the P wave to the end
Measured: At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable
Paced P-wave duration
Measured from the pacing stimulus to P wave end duration
Measured: From implantation to regular follow-ups up to 24 months
Left ventricular ejection fraction (LVEF)
Standard transthoracic echocardiographic parameter
Measured: At baseline, 6-, 12-, and 24-month follow-ups
Left atrial diameter (LAD)
Standard transthoracic echocardiographic parameter
Measured: At baseline, 6-, 12-, and 24-month follow-ups
Right atrial diameter (RAD)
Standard transthoracic echocardiographic parameter
Measured: At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-systolic diameter (LVESD)
Standard transthoracic echocardiographic parameter
Measured: At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-diastolic diameter （LVEDD）
Standard transthoracic echocardiographic parameter
Measured: At baseline, 6-, 12-, and 24-month follow-ups
E/e'
Standard transthoracic echocardiographic parameter
Measured: At baseline, 6-, 12- , 24-month follow-ups
Mitral regurgitation severity
Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe)
Measured: At baseline, 6-, 12- , 24-month follow ups
Tricuspid regurgitation severity
Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe)
Measured: At baseline, 6-, 12-, 24- month follow-ups
NT-pro BNP
Standard transthoracic echocardiographic parameter
Measured: At baseline, before discharge, and 6-month follow-up
eGFR
Measured: At baseline, before discharge, and 6 - month follow-up
All-cause mortality
Measured: From implantation to regular follow-ups up to 24 months
Cardiovascular death
Measured: From implantation to regular follow-ups up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start25 Aug 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacing TherapyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645066
- Sponsor's protocol ID
- PSB-AF
- Acronym
- PSB-AF
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial Evaluating the Effect of Posterosuperior Bundle Pacing on Atrial Fibrillation Prevention in Patients With Sinus Node Dysfunction
- ClinicalTrials.gov ID
- NCT07645066
- Acronym / sponsor ID
- PSB-AF / PSB-AF
- Conditions
- Pacing Therapy, Cardiac Pacing
- Keywords
- Posterosuperior bundle pacing, Right atrial appendage pacing, Physiological pacing, atrial pacing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 12 Jun 2026 (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 study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation. Approximately 300 patients will be enrolled and randomized to receive atrial pacing at either the PSB region or the right atrial appendage (RAA). The primary endpoint is the occurrence of AF episodes lasting ≥6 minutes, as detected by device or surface electrocardiogram. Patients will be followed for up to 24 months.
Detailed description
Sinus node dysfunction (SND) is a common indication for permanent pacemaker implantation. Conventional right atrial appendage (RAA) pacing may result in delayed or dyssynchronous atrial activation, potentially increasing the risk of atrial arrhythmias. Posterosuperior bundle (PSB) pacing is a novel physiological atrial pacing approach. This study is a prospective, multicenter, open-label, randomized controlled trial. A total of approximately 300 eligible SND patients indicated for pacemaker implantation will be enrolled and randomly assigned (1:1) to PSB pacing or RAA pacing. Ventricular pacing will be performed using left bundle branch area pacing in both groups. Following implantation, the pacemaker will be programmed in DDD mode with a lower rate of 70 beats/min during daytime and 60 beats/min during nighttime. Rate-responsive pacing will be enabled by default when available; ATP will be disabled by default. Participants will be followed at 3, 6, 12, and 24 months after implantation. The primary endpoint is the occurrence of AF episodes lasting ≥6 minutes. Secondary endpoints include atrial high-rate episodes, AF burden, pacing parameters, ECG and echocardiographic indices, laboratory findings, and mortality outcomes. Safety endpoints include procedural complications and device-related adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSB pacing | Experimental | Procedure: PSB pacingPatients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures. |
| RAA pacing | Active comparator | Procedure: RAA pacingPatients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years
- Indication for permanent pacemaker implantation, including:
- Sinus node dysfunction, defined as at least one of the following:
- Symptomatic sinus bradycardia
- Tachy-brady syndrome
Key exclusion criteria (9 listed)
- Persistent atrial fibrillation (AF) (>7 days), long-standing persistent AF, permanent AF, or prior atrioventricular node ablation
- Prior cardiac implantable electronic device (CIED) requiring replacement, upgrade, or revision
- Indication for cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT-D)
- Prior cardiac surgery, severe hepatic or renal dysfunction, or other life-threatening systemic diseases
- Acute myocardial infarction within 3 months before enrollment
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 |
|---|---|---|
| RAA pacingAtrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary. | Procedure or surgery | RAA pacing |
| PSB pacingAtrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary. | Procedure or surgery | PSB pacing |
Primary outcome
Incidence of atrial fibrillation
Time frame: From implantation to regular follow-ups up to 24 months
Incidence of atrial fibrillation ≥ 6 minutes during follow-ups
16 secondary outcomes
Atrial high-rate episodes
Time frame: From implantation to regular follow-ups up to 24 months
AF burden
Time frame: From implantation to regular follow-ups up to 24 months
Intrinsic P-wave duration
Time frame: At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable
Paced P-wave duration
Time frame: From implantation to regular follow-ups up to 24 months
Left ventricular ejection fraction (LVEF)
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Left atrial diameter (LAD)
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Right atrial diameter (RAD)
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-systolic diameter (LVESD)
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-diastolic diameter （LVEDD）
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
E/e'
Time frame: At baseline, 6-, 12- , 24-month follow-ups
Mitral regurgitation severity
Time frame: At baseline, 6-, 12- , 24-month follow ups
Tricuspid regurgitation severity
Time frame: At baseline, 6-, 12-, 24- month follow-ups
NT-pro BNP
Time frame: At baseline, before discharge, and 6-month follow-up
eGFR
Time frame: At baseline, before discharge, and 6 - month follow-up
All-cause mortality
Time frame: From implantation to regular follow-ups up to 24 months
Cardiovascular death
Time frame: From implantation to regular follow-ups up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAA pacing and PSB pacing in people with Pacing Therapy and Cardiac Pacing, run by Shanghai Tong Ren Hospital at 10 sites 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Qiu (+862152039999, qzh3503@shtrhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial fibrillation (time frame: From implantation to regular follow-ups up to 24 months). 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 23 Sep 2026.