A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 4
- 主要终点
- Number of patients wit successfull pulmonary vein isolation
研究概览
简要总结
Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
详细描述
Rationale Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.
Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Study design The study is designed as a prospective multicentre randomized efficacy study.
Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
- •Age < 70 years.
- •Willing and able to sign informed consent.
- •Willing to and capable of following the requested study procedures.
排除标准
- •Age < 18 years.
- •Pregnancy
- •Life or follow-up expectancy < 12 months.
- •Previous PVI.
- •Contrast allergy.
- •Creatin clearance level <
- •Left ventricular ejection fraction < 40%
- •Abnormal left atrium anatomy defined as number of PV's ≠ 4 or Left Atrium diameter >50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or >40 cc/m2 . This will lead to exclusion after inclusion but before randomisation.
结局指标
主要结局
Number of patients wit successfull pulmonary vein isolation
时间窗: up to 6 minutes
Assessment of successfull pulmonary vein isolation after 2 x 1/2/3 minutes of cryoballoon application. The assessment of this outcome will take place during the procedure.
次要结局
- Number of complications(1 year)
- Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present(up to 6 minutes)
- Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation(up to 6 minutes)
- Lower Esophageal Temperature development(up to 6 minutes)
- Procedure time, fluoroscopy time, amount of contrast used(up to 6 minutes)
- Atrial Fibrillation recurrence(after 1 year follow up)
- Balloon temperatures measured by the console(up to 6 minutes)
研究者
Harald Verheij
Drs.
Thorax Centrum Twente