NCT05324540Unknown不适用
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
MediCool Technologies0 个研究点目标入组 30 人开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Termination of atrial fibrillation
研究概览
简要总结
An assessment of the use of cold therapy to terminate atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Subject must be ≥ 18 years or older
- •Male of female
- •Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration
- •Must be in AF at time of surgery, or inducible using manual or electrical stimulation
- •Subject is willing and able to provide written informed consent
- •Subject has a life expectancy of at least 1 year
排除标准
- •Exclusion Criteria: • Long-standing AF (duration > 1 year)
- •Prior AF ablation
- •Left main coronary artery occlusion > 70%
- •Critical aortic stenosis (gradient > 50mm HG)
- •Inability to induce patient into AF without drugs at time of surgery
- •Female subjects who are pregnant at time of surgery
- •Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study
- •Permanent pacemaker or implantable cardioverter defibrillator
- •Current cancer treatment that includes radiation of the heart
- •Inability to give informed consent
- •Significant intra-cardiac thrombus
- •Subjects not eligible for or considered high risk for anticoagulation
结局指标
主要结局
Termination of atrial fibrillation
时间窗: Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected.
Number of successful terminations of atrial fibrillation to normal sinus rhythm upon application of cool therapy will be measured and assessed.
次要结局
- Time to termination(Time to termination will be assessed only during each application. No longer term data will be collected.)
研究者
相似试验
终止
不适用
CoolLoop Paroxysmal Atrial FibrillationAtrial Fibrillation (Paroxysmal)Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesNCT02553239afreeze GmbH20
已完成
不适用
Cryoablation of Atrial Fibrillation Using a Novel Cryoablation SystemAtrial FibrillationNCT01687036afreeze GmbH10
Unknown
不适用
Ablation of Atrial Fibrillation in Heart Failure PatientsSevere Heart FailureAtrial FibrillationNCT03062241Medical University of Silesia330
已完成
不适用
Cryoablation as Standard Treatment of Atrial FlutterAtrial FlutterNCT01604369Karolinska University Hospital193
已完成
不适用
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)Atrial FibrillationNCT02213731Medtronic Cardiac Ablation Solutions130