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LBBAP vs. CS Pacing for CRT in Permanent Atrial Fibrillation and Heart Failure (SYNC-AF)

NCT07560891 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Left Bundle Branch Area Pacing (LBBAP) for CRT

CRT device (CRT-P or CRT-D) implantation using LBBAP as the left ventricular pacing lead. A pacing lead is advanced through the interventricular septum to achieve left bundle branch area capture, confirmed by pacing parameters and electrocardiographic criteria (RBBB-like pattern with short R-peak latency in V5/V6). RV lead is implanted in standard fashion. AVJ ablation may be performed per clinical indication.

DEVICE

Coronary Sinus (CS) Lead-Based Biventricular CRT

CRT device (CRT-P or CRT-D) implantation using a conventional coronary sinus (CS) lead as the left ventricular pacing lead. The CS lead is advanced via the coronary sinus into a lateral or posterolateral cardiac vein to achieve biventricular pacing. RV lead is implanted in standard fashion. AVJ ablation may be performed per clinical indication.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07560891 on ClinicalTrials.gov