INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.
研究概览
简要总结
The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.
详细描述
This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy.
After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups:
- Control group: resynchronization via a transvenous left ventricular lead (TVN CRT);
- Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT).
All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads.
Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
- •Have a stable pharmacological therapy.
排除标准
- •Have a contra-indication to general anesthesia;
- •Have a scheduled cardiac surgery;
- •Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
- •Have a life expectancy of less than 6 months;
- •Are unable to provide informed consent;
- •Are unable to comply with the follow-up schedule and tests;
- •Are minor (age below 18 years);
- •Are pregnant or are planning for pregnancy in the next 6 months.
研究组 & 干预措施
Transvenous Lead (TVN CRT)
Control group: resynchronization via a transvenous left ventricular lead (TVN CRT)
干预措施: Cardiac Resynchronization Therapy implant (Device)
Epicardial Lead (EPI CRT)
Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT)
干预措施: Cardiac Resynchronization Therapy implant (Device)
结局指标
主要结局
The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.
时间窗: 6 months follow up after implant
次要结局
未报告次要终点