About this trial
This is a prospective, multicenter, randomized controlled trial comparing Left Bundle Branch Area Pacing (LBBAP)-based cardiac resynchronization therapy (CRT) with conventional coronary sinus (CS) lead-based CRT in patients with permanent atrial fibrillation (AF) and heart failure (HF) who meet indications for CRT device implantation.
Atrial fibrillation and heart failure frequently coexist, and both rapid heart rate and its irregularity contribute to worsening cardiac function. Atrioventricular junction (AVJ) ablation combined with CRT (biventricular pacing) has been established as an effective strategy for rate control and cardiac resynchronization in this population, supported by Class I recommendation in the 2021 ESC guidelines. However, conventional biventricular CRT via the CS lead can induce artificial electrical dyssynchrony, particularly in patients with a narrow QRS complex, potentially limiting its benefit.
Conduction system pacing (CSP), including LBBAP, has emerged as a physiologic alternative that directly stimulates the native conduction system, preserving synchronous ventricular activation. Recent evidence (ALTERNATIVE-AF trial) suggests CSP may be superior to biventricular CRT in permanent AF patients undergoing AVJ ablation. However, no randomized controlled trial has directly compared LBBAP-based CRT with CS lead-based CRT in this specific population.
The SYNC-AF trial will randomize 44 patients (22 per arm) to either LBBAP or CS pacing for CRT. The primary endpoint is change in left ventricular ejection fraction (LVEF) at 12 months as assessed by echocardiography in a blinded core laboratory. Secondary endpoints include changes in QRS duration, major adverse clinical events, device/procedure-related complications, and ventricular arrhythmia burden.
Eligibility criteria
Qualifiers
Age ≥19 years
Indication for CRT (CRT-P or CRT-D) device implantation per current guidelines
Permanent atrial fibrillation (with or without planned AVJ ablation)
Ability to understand the purpose of the study and provide written informed consent
Disqualifiers
Prosthetic tricuspid valve
Prior myocardial infarction involving the interventricular septal area
Life expectancy less than 12 months
Unable to comply with planned 12-month follow-up for any reason
Trial design
Treatments tested in this trial
- Left Bundle Branch Area Pacing (LBBAP) for CRT
- Coronary Sinus (CS) Lead-Based Biventricular CRT