Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,125
- 试验地点
- 1
- 主要终点
- Atrial fibrillation or atrial flutter
研究概览
简要总结
The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark.
A cluster randomization study tests standardized treatments by rotating the treatments over time periods. All patients will be treated with the specific standard treatment of the period and will be informed about the study. The patient will have the option to decline their participatiion in the study in writing and their data will not be collected.
The main purpose of the study is to investigate whether one of more of the systems are more efficient in preventing AF or atrial flutter during the following 12 months. Additionally, the safety of the systems are compared to see if one or more are more efficient in preventing complications 30 days after the ablation procedure.
The patients will receive standard treatment according to the cluster at the time of their ablation and data for up to 12 months post procedure will be collected by medicial chart review.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18 years or older
- •Planned Catheter Ablation of Atrial Fibrillation with Pulmonary Vein Isolation
排除标准
- •- Opt out of data collection
研究组 & 干预措施
FARAPULSE and FARAVIEW
PFA system
干预措施: Pulse field ablation Systems (Device)
VARIPULSE
PFA system
干预措施: Pulse field ablation Systems (Device)
PULSE-SELECT and AFFERA
PFA system
干预措施: Pulse field ablation Systems (Device)
Arctic Front Advance Cardiac Cryoablation Catheter
Ablation system
干预措施: Pulse field ablation Systems (Device)
VOLT
PFA system
干预措施: Pulse field ablation Systems (Device)
结局指标
主要结局
Atrial fibrillation or atrial flutter
时间窗: 12 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Atrial fibrillation or atrial flutter
时间窗: 6 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Atrial fibrillation or atrial flutter
时间窗: 3 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
次要结局
- Hospitalization due to atrial fibrillation or flutter(12 months post procedure)
- Hospitalization due to atrial fibrillation or flutter(6 months post procedure)
- Patient reported outcome measures(12 month)
- Patient reported outcomes measures(6 month)
- Patient reported outcomes measures(3 month)
- Antiarrhythmic medications(12 months post procedure)
- Antiarrhythmic medications(6 months post procedure)
- Duration of the procedure(Post procedure)
- Safety of the system(30 days post procedure)
研究者
Peter Karl Jacobsen
MD
Rigshospitalet, Denmark
