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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.
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. Participants will be followed at 3, 6, 12, and 24 months after implantation. An interim analysis will be conducted after 100 patients complete the 6-month follow-up.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSB pacing | Experimental | Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures. |
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| RAA pacing | Active Comparator | Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAA pacing | Procedure | Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of atrial fibrillation | Incidence of atrial fibrillation ≥ 6 minutes during follow-ups | From implantation to regular follow-ups up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial high-rate episodes | From implantation to regular follow-ups up to 24 months | |
| AF burden | From implantation to regular follow-ups up to 24 months | |
| Intrinsic P-wave duration |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural complications | Safety Outcome | Perioperative |
| Postoperative adverse events | Safety Outcome, including lead-related complications, thromboembolic events, etc. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Qiu | Contact | +862152039999 | qzh3503@shtrhospital.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University affiliated AnQing Municipal Hospital | Anqing | Anhui | China |
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| PSB pacing | Procedure | Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary. |
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Measured from the onset of the P wave to the end |
| 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 | From implantation to regular follow-ups up to 24 months |
| Left ventricular ejection fraction (LVEF) | Standard transthoracic echocardiographic parameter | At baseline, 6-, 12-, and 24-month follow-ups |
| Left atrial diameter (LAD) | Standard transthoracic echocardiographic parameter | At baseline, 6-, 12-, and 24-month follow-ups |
| Right atrial diameter (RAD) | Standard transthoracic echocardiographic parameter | At baseline, 6-, 12-, and 24-month follow-ups |
| Left ventricular end-systolic diameter (LVESD) | Standard transthoracic echocardiographic parameter | At baseline, 6-, 12-, and 24-month follow-ups |
| Left ventricular end-diastolic diameter (LVEDD) | Standard transthoracic echocardiographic parameter | At baseline, 6-, 12-, and 24-month follow-ups |
| E/e' | Standard transthoracic echocardiographic parameter | 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) | 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) | At baseline, 6-, 12-, 24- month follow-ups |
| NT-pro BNP | Standard transthoracic echocardiographic parameter | At baseline, before discharge, and 6-month follow-up |
| eGFR | At baseline, before discharge, and 6 - month follow-up |
| All-cause mortality | From implantation to regular follow-ups up to 24 months |
| Cardiovascular death | From implantation to regular follow-ups up to 24 months |
| From implantation to regular follow-ups up to 24 months |
| Atrial pacing capture threshold | From implantation to regular follow-ups up to 24 months |
| Atrial sensing amplitude | From implantation to regular follow-ups up to 24 months |
| Atrial pacing output | From implantation to regular follow-ups up to 24 months |
| Paced P-wave morphology | positive, negative, notched, and biphasic | From implantation to regular follow-ups up to 24 months |
| Intrinsic P-wave morphology | positive, negative, notched, and biphasic | At baseline, implant, and regular follow-ups up to 24 months when intrinsic atrial rhythm is assessable |
| Tongling People's Hospital | Tongling | Anhui | China |
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| Affiliated Hospital of Zunyi Medical College | Zunyi | Guizhou | China |
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| Wuhan Asia General Hospital | Wuhan | Hubei | China |
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| Tong Ren Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200336 | China |
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| Fudan University affiliated Huadong Hospital | Shanghai | Shanghai Municipality | China |
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| Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | China |
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| Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
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| Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital | Shanghai | Shanghai Municipality | China |
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| Tongji University School of Medicine affiliated Tongji University | Shanghai | Shanghai Municipality | China |
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