Effectiveness and Safety of Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Freedom from VC recurrence
研究概览
简要总结
This randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ICE)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing PVC recurrence among patients with confirmed papillary muscle-originating premature ventricular contractions (PVCs). Participants were randomly allocated to either the ICE-guided intervention group or the conventional ablation control group following definitive diagnosis.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years.
- •Diagnosed with premature ventricular contractions (PVCs) originating from the papillary muscles.
- •Symptoms refractory to antiarrhythmic drug therapy.
- •Patients must be capable and willing to provide written informed consent for study participation.
排除标准
- •History of cardiac surgery or any prior cardiac interventional procedures.
- •Ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- •Severe hepatic or renal dysfunction:
- •AST/ALT >3× upper limit of normal (ULN); Serum creatinine (SCr) >3.5 mg/dl or creatinine clearance (Ccr) <30 ml/min.
- •Prior ablation for papillary muscle PVCs.
- •Life expectancy <1 year.
- •Pregnancy or lactation.
结局指标
主要结局
Freedom from VC recurrence
时间窗: Patients were followed up at 3 months postoperatively to assess recurrence.
Freedom from VC recurrence (defined as a ≥80% reduction in VC burden, calculated as \[number of VCs per 24 hours / total number of heartbeats per 24 hours\] × 100%).
次要结局
- VC burden reduction(Patients were followed up at 3 months postoperatively to assess recurrence.)
- Total procedure time(From the start to the end of the procedure.)
- Total fluoroscopy time(From the start to the end of the procedure.)
- Major perioperative complications(30 days postoperatively.)
研究者
Xu Liu
Professor
Shanghai Chest Hospital