Safety and efficacY of conductioN System paCing and Atrioventricular Junctional Ablation Combined With ICD Implantation in Patients With End-stage Heart Failure and Atrial Fibrillation Eligible for Heart Transplantation (SYNC AF-HTx) : Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of conduction system pacing (CSP) using left bundle branch pacing (LBBP) and atrioventricular junction (AVJ) ablation in patients with end-stage heart failure and permanent atrial fibrillation (AF). Participants who are candidates for heart transplantation or left ventricular assist device (LVAD) implantation will be randomized to either the SYNC group (ICD implantation combined with LBBP and AVJ ablation) or the control group (ICD implantation only). The investigators will compare clinical outcomes, including mortality and heart failure hospitalization, between the two strategies over a 1-year follow-up period.
详细描述
End-stage heart failure patients often face a poor prognosis due to comorbid permanent AF, which leads to irregular heart rates and worsens ventricular function. While implantable cardioverter-defibrillators (ICDs) are standard for preventing sudden cardiac death, they may not sufficiently prevent heart failure progression in patients with narrow QRS complexes. This study explores a "SYNC" strategy using LBBP and AVJ ablation to achieve ventricular synchronization and heart rate regularization. This is a multicenter, prospective, randomized (1:1), single-blind trial involving 120 participants.
Inclusion Criteria: Participants must have LVEF≤35%, permanent AF for >6 months, and be eligible for ICD implantation while awaiting heart transplantation or LVAD.
Intervention (SYNC Group): Participants receive an ICD with an LBBP lead (Medtronic SelectSecure™ 3830) and undergo AVJ ablation.
Control Group: Participants receive standard ICD implantation with a minimal ventricular pacing setting.
Follow-up: Clinical assessments, echocardiography, and device profiles will be monitored at baseline, 1, 3, 6, and 12 months post-procedure.
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 (Participant)
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
- •Candidates for ICD implantation (primary or secondary prevention). Permanent AF (>6 months) unsuitable for or failed catheter ablation. End-stage heart failure considering heart transplant or LVAD. LVEF ≤ 35 within 6 weeks before enrollment. NYHA functional class ≥ II. On GDMT for at least 3 months. Age ≥ 19 years.
排除标准
- •Existing LVAD or prior heart transplantation. Indications for cardiac resynchronization therapy (CRT). History of mechanical tricuspid valve replacement. Expected survival≤ 12 months. Inability to comply with the study protocol.
研究组 & 干预措施
SYNC group
Combined procedure of ICD implantation, LBBP lead insertion, and AVJ ablation.
干预措施: LBBP + AVJ Ablation with ICD (Device)
Control group
Standard ICD implantation with minimal ventricular pacing strategy.
干预措施: ICD Only (Device)
结局指标
主要结局
Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation
时间窗: Time Frame: Up to 12 months
Occurrence of the first event among the composite components
次要结局
- Urgent heart transplantation(Up to 12 months)
- LV systolic function(6months and 12months)
- All cause mortality(Up to 12 months)
- Cardiovascular mortality(Up to 12 months)
- Heart failure hospitalization(Up to 12 months)