The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- afreeze GmbH
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Positioning of the Rodeo Micro Mapping Catheter
研究概览
简要总结
This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted).
Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years and legal capacity.
- •Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version 2016) - permanent AF excluded.
- •Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU).
- •Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrolment (patient has received a copy of the ICF).
排除标准
- •Indication that the vascular system is not accessible through the left or right groin.
- •Indication that a transseptal puncture cannot be performed.
- •Any previous ablation or surgery due to AF.
- •Important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients.
- •Left atrial diameter > 50 mm in the short axis.
- •Advanced structural heart disease including
- •moderate-to-severe valvular stenosis or regurgitation,
- •previous valve replacement or valve repair,
- •congenital heart disease,
- •left ventricular ejection fraction < 45% during sinus rhythm,
- •congestive heart failure NYHA III or IV,
- •coronary artery bypass graft surgery within the last 3 months.
- •Permanent pacemaker.
- •Pregnant women at the time of the cryoablation procedure.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
- •Participation in interventional trials for cardiovascular devices or drugs.
结局指标
主要结局
Positioning of the Rodeo Micro Mapping Catheter
时间窗: 1-3 hours
Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible
Feasibility of the Rodeo Micro Mapping Catheter
时间窗: 1-3 hours
Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter.
次要结局
- Safety of the Rodeo Micro Mapping Catheter.(1-3 day follow-up period)
- Efficacy of the Rodeo Micro Mapping Catheter(1-3 hours)
- Real-time pulmonary vein isolation(1-3 hours)
- Total procedure time(1-3 hours)
- Total fluoroscopy time and dose(1-3 hours)
- Procedural safety(1-3 hours)
- Cryoablation catheter procedure time(1-3 hours)
- Cryoablation catheter fluoroscopy time and dose(1-3 hours)