NCT04334018撤回不适用
Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.
CMC Ambroise Paré12 个研究点 分布在 2 个国家开始时间: 2018年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 12
- 主要终点
- Outcome 1
研究概览
简要总结
The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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 with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months
排除标准
- •< 18 years and younger
- •Pregnant or breastfeeding patients
- •Non-LBBB patients (RBBB, intra-ventricular delay)
- •Non-ambulatory NYHA class IV effort tolerance
- •Myocardial infarction within 40 days before enrolment
- •Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months
- •Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)
- •Patients with life expectancy of less than 12 months due to other medical conditions
- •Patients who are involved in another investigational study (device or medical)
结局指标
主要结局
Outcome 1
时间窗: 12 months
To evaluate the clinical improvement of CRT MPP as compared to conventional CRT in Heart Failure patients with indication for CRT using automated intra-cardiac EGMs analysis (QuickOpt™) for device optimization, in a large multicentre international study.
次要结局
未报告次要终点
研究者
研究点 (12)
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