Left Bundle Branch Area Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy for Patients With Permanent Atrial Fibrillation and Heart Failure: The SYNC-AF Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- Change from Baseline Left Ventricular Ejection Fraction (LVEF) at 12 Months
研究概览
简要总结
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.
详细描述
ECHOCARDIOGRAPHIC CORE LAB:
All echocardiographic assessments (LVEF, LVESV, LVEDV, etc.) are performed and interpreted by a blinded independent core laboratory at Severance Hospital to ensure objective and consistent measurement.
FOLLOW-UP SCHEDULE:
Screening (implant day) → Visit 1 (2 weeks-1 month) → Visit 2 (3 months ±3 months) → Visit 3 (6 months ±3 months) → Visit 4 (12 months ±3 months).
STATISTICAL ANALYSIS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open-label study. Participants, care providers, and investigators are not masked to treatment allocation. However, echocardiographic outcome assessors at the blinded central core laboratory are masked to treatment assignment.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •History of heart transplantation
- •Persistent left superior vena cava (PLSVC)
研究组 & 干预措施
LBBAP Group
Participants undergo CRT device implantation (CRT-P or CRT-D) with Left Bundle Branch Area Pacing (LBBAP) as the left ventricular lead strategy. LBBAP is attempted first; if not feasible, crossover to CS lead is permitted. AVJ ablation is performed per clinical indication.
干预措施: Left Bundle Branch Area Pacing (LBBAP) for CRT (Device)
CS Pacing Group
Participants undergo CRT device implantation (CRT-P or CRT-D) with conventional Coronary Sinus (CS) lead-based pacing as the left ventricular lead strategy. AVJ ablation is performed per clinical indication.
干预措施: Coronary Sinus (CS) Lead-Based Biventricular CRT (Device)
结局指标
主要结局
Change from Baseline Left Ventricular Ejection Fraction (LVEF) at 12 Months
时间窗: Baseline (at the time of device implantation) and 12 months post-implantation
Change in left ventricular ejection fraction (LVEF) from baseline to 12 months post-implantation, as measured by transthoracic echocardiography performed and interpreted by a blinded independent central core laboratory. LVEF is assessed using the biplane Simpson method.
次要结局
- Proportion of patients with absolute LVEF increase ≥5% at 12 months(12 months post-implantation)
- Proportion of patients with absolute LVEF increase ≥10% at 12 months(12 months post-implantation)
- Change in QRS Duration From Baseline(Immediately post-implant and at 12 months)
- Time to First Treated Ventricular Arrhythmia(Up to 12 months)
- Composite of All-Cause Death and Heart Failure Hospitalization(Up to 12 months (first occurrence))
- All-cause mortality(Up to 12 months (first occurrence))
- Heart failure hospitalization(Up to 12 months (first occurrence))
- Cardiovascular death(Up to 12 months (first occurrence))
- Immediate procedural success rate of LBBAP lead implantation(Immediately after the implantation procedure)
- Lead capture loss rate at 12 months(12 months post-implantation)
- Composite Rate of Worsening Heart Failure by Echocardiographic Criteria(Up to 12 months)
- Device and Procedure-Related Complications(Up to 12 months (device/procedure-related complications within 7 days for acute; up to 12 months for chronic))
- Reintervention Rate(Up to 12 months)