Cardiac Pacing, Pacing Therapy
Conditions
Keywords
Posterosuperior bundle pacing, Right atrial appendage pacing, Physiological pacing, atrial pacing
Brief 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. 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. 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.
Interventions
PROCEDURERAA pacing
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
PROCEDUREPSB pacing
Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
Sponsors
Shanghai Tong Ren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of atrial fibrillation | From implantation to regular follow-ups up to 24 months | Incidence of atrial fibrillation ≥ 6 minutes during follow-ups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable | Measured from the onset of the P wave to the end |
| Paced P-wave duration | From implantation to regular follow-ups up to 24 months | Measured from the pacing stimulus to P wave end duration |
| Left ventricular ejection fraction (LVEF) | At baseline, 6-, 12-, and 24-month follow-ups | Standard transthoracic echocardiographic parameter |
| Left atrial diameter (LAD) | At baseline, 6-, 12-, and 24-month follow-ups | Standard transthoracic echocardiographic parameter |
| Right atrial diameter (RAD) | At baseline, 6-, 12-, and 24-month follow-ups | Standard transthoracic echocardiographic parameter |
| Left ventricular end-systolic diameter (LVESD) | At baseline, 6-, 12-, and 24-month follow-ups | Standard transthoracic echocardiographic parameter |
| Left ventricular end-diastolic diameter （LVEDD） | At baseline, 6-, 12-, and 24-month follow-ups | Standard transthoracic echocardiographic parameter |
| E/e' | At baseline, 6-, 12- , 24-month follow-ups | Standard transthoracic echocardiographic parameter |
| Mitral regurgitation severity | At baseline, 6-, 12- , 24-month follow ups | Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe) |
| Tricuspid regurgitation severity | At baseline, 6-, 12-, 24- month follow-ups | Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe) |
| NT-pro BNP | At baseline, before discharge, and 6-month follow-up | Standard transthoracic echocardiographic parameter |
| 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 | — |
Countries
China
Contacts
CONTACTZhaohui Qiu
Outcome results
None listed