NCT06482840进行中（未招募）不适用
Safety and Efficacy of EasyCool Catheter - Prospective Monocentric Study
MedFact Engineering GmbH1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Removal of treated cardiac arrythmia
研究概览
简要总结
The goal of this observational study is to learn about risks and benefit of EasyCool Catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias.
The main question[s] it aims to answer are:
- will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure
- what are the adverse events at procedure, after 3 and 6 months
All participants will receive cardiac ablation with EasyCool catheter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring intracardial RF- Ablation with irrigated catheter
排除标准
- •Absence of patient´s consent;
- •Age <12 years;
- •Pregnancy or breast-feeding women;
- •Acute local infection;
- •Acute systemic infection;
- •Atrial thrombosis or myxoma - the transseptal approach is contraindicated in patients with left atrial thrombus;
- •Existence of active Implants (Pacemaker, Defibrillator etc.);
- •Hemodynamic instability;
- •Hypercoagulability;
- •Inadequate tissue damaged e.g. by radiation or suppuration;
- •Obstruction of the artery or vein selected for insertion;
- •Patients with artificial heart valve: the use of intracardial catheters is not advised;
- •Physiologic or anatomic abnormalities that could cause postoperative complications e.g. aneurysms in the application area, bleeding diathesis, decreased resistance to infections;
- •Previously diagnosed spasms of the coronary arteries;
- •Recurrent metastasizing cancer;
- •Severe concomitant illness for which an increase or surgery time is associated with a significant increased risk;
- •Thrombosis of the leg veins and the deep pelvic vein.
结局指标
主要结局
Removal of treated cardiac arrythmia
时间窗: 3 months after procedure
Removal of treated cardiac arrhythmia and absence of recurrence of the arrythmia
次要结局
- Adverse Events(at procedure, after 3 and 6 months)
研究者
研究点 (1)
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