Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- mid term success
研究概览
简要总结
The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF).
The main aims of the study are:
- to compare the efficacy of two ablation devices (acute and 1 year success rates)
- to compare the procedural characteristics (procedure duration, fluoroscopy duration, ablation time
- to compare the complication rates
Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon. Standard of care cryoballoon procedure will be performed alongside with standard postprocedural follow-up.
• to compare the complication rates
Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon.
详细描述
Patients suffering from paroxysmal atrial fibrillation who are scheduled (independently of this study) for cryoballoon pulmonary vein isolation will be informed about the study and potential risks. All patients who give written informed consent will be randomized to 4th generation Artic Front Advance Pro device (fixed size balloon of 28 mm) and Polar X Fit device (28-31 mm expandable balloon). The ablation procedure will be performed in standard of care fashion. Also, standard postprocedural follow up of the patients will be scheduled with outpatient clinic visits and 24-hour Holters and 3, 6 and 12 months, and yearly thereafter. Extra visits will be scheduled in the case of symptoms/palpitations.
Standard patient and procedural data will be collected alongside with the information obtained in the follow up.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •paroxysmal atrial fibrillation
- •patient scheduled for cryoballoon pulmonary vein isolation regardless of this study
排除标准
- •unwilling to sing the informed consent Left atrium size > 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
结局指标
主要结局
mid term success
时间窗: 1 year. Outpatient visits planned on 90, 180 and 360 days.
number of patients free from atrial arrhythmia (atrial fibrillation detected by ECG or Holter monitors on follow up visits)
acute success
时间窗: 1 week
successful pulmonary vein isolation, as percentage of all pulmonary veins treated
次要结局
- ablation time(1 week)
- radiation dosage(1 week)
- fluoroscopy time(1 week)
- procedure duration(1 week)
- complications(1 year)
研究者
Vedran Velagic
MD, PhD, Assistant Professor
University of Zagreb