Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Atrial Fibrillation Recurrence
研究概览
简要总结
The purpose of this study is to develop and prospectively test two Cryo-AF (atrial fibrillation) dosing protocols guided exclusively by time-to-isolation (TT-I) in patients undergoing a first-time Cryo-AF.
Both protocols guided by TT-I are associated with shorter cryoapplications as compared to conventional approach.
In the first group freeze duration is TTI +120 s. In the second group freeze duration is 240s if TTI is < 75 s. In case of TTI>75s a 240s bonus freeze is applied.
The investigators examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.
The study cohort consists of consecutive patients undergoing a first-time Cryo-AF for symptomatic paroxysmal or persistent AF (atrial fibrillation) at Interventional Cadiology and Cardiac Arrhythmias Clinic of Medical University in Łódź. During 12 months investigators are planning to enroll 40 patients Patients are randomly assigned to the groups. All of them will be followed up 3 and 12 months after the procedure. In addition, ambulatory electrocardiographic monitoring will also be performed at 3 and 12 months.
The study is requested for an approval of the university ethics committee.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram
排除标准
- •Diagnosis of Sinus Rhythm on Electrocardiogram
研究组 & 干预措施
Freeze cycle: 240 s - TTI <75 s or 2x240 s - >75 s
In the first group freeze duration is 240s if TTI (time-to-isolation) is < 75 s. In case of TTI>75s a 240s bonus freeze is applied.
If no TTI could be documented, a single 240 s freeze cycle is applied in this group in case of balloon temperature -40°C (degrees Celsius) after 60 s.
干预措施: Cryoballoon pulmonary vein isolation (Procedure)
Freeze cycle: TTI+120 s
In the second group freeze duration is TTI (time-to-isolation) +120 s. If no TTI could be documented, a single 180 s freeze cycle is applied in this group in case of balloon temperature -40 °C after 60 s.
干预措施: Cryoballoon pulmonary vein isolation (Procedure)
结局指标
主要结局
Atrial Fibrillation Recurrence
时间窗: 12 months after the procedure
Atrial Fibrillation Recurrence
时间窗: 3 months after the procedure
次要结局
未报告次要终点
研究者
Izabela Warchol
Principal Investigator
Medical University of Lodz