Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Atrial tachycardia and/or atrial fibrillation (AT/AF) free survival
研究概览
简要总结
Prospective multicenter observational study evaluating the performance of pressure wave-guided atrial fibrillation cryoablation used in accordance with clinical practice guidelines.
详细描述
The POLAR-WAVE registry is a prospective, multi-center, single-arm study evaluating the efficacy and safety of pressure-guided atrial fibrillation cryoablation, where the occlusion of pulmonary veins will be assessed by pressure waveforms (instead of contrast), over a follow-up period of 12 months.
This is a non-commercial, investigator-driven clinical study, coordinated by the main investigator from University Hospital "12th of October", Madrid, Spain. Several responsibilities are delegated to the Clinical Research Unit (University Hospital "12th of October", Madrid, Spain).
The study was planned according to the Good Clinical Practices. POLAR-WAVE Study has been approved by the Ethics Committee and Spanish Health Authorities. All participating patients must give written informed consent.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •Paroxysmal, persistent, or long-lasting persistent atrial fibrillation.
- •Indication of pulmonary vein ablation according to clinical practice guidelines.
排除标准
- •Previous ablation of atrial fibrillation.
- •Thrombus in the left atrium.
- •Rheumatic heart disease.
- •Hypertrophic cardiomyopathy.
- •Absolute contraindication to anticoagulation.
- •Women in a state of pregnancy, lactation or childbearing age without contraception.
- •Life expectancy < 1 year.
结局指标
主要结局
Atrial tachycardia and/or atrial fibrillation (AT/AF) free survival
时间窗: 12 months
Proportion of patients without AT/AF episodes (excluding a window period of 3 months from ablation)
次要结局
- Temperature parameters obtained during pressure guided cryoablation procedures (global and for each vein)(1 day)
- Performance of pressure guided cryoablation procedures(1 day)
- Symptoms associated with atrial fibrillation(12 months)
- Safety events(30 days)
- Radiation dose(1 day)
- Acute results of pressure guided cryoablation procedures (global and for each vein)(1 day)
- Successfully completed ablation procedures(12 months)
- Time parameters obtained during pressure guided cryoablation(1 day)
研究者
Adolfo Fontenla
Principal Investigator
Quirón Madrid University Hospital