A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation. Results of the the plusONE Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Atrial fibrillation-free survival, without antiarrhythmic drug therapy
研究概览
简要总结
This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary vein ablation procedures in patients with paroxysmal atrial fibrillation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 2 documented episodes of paroxysmal Atrial Fibrillation (AF) which are not responders to at least one antiarrythmic drug
排除标准
- •Previous left atrial ablation procedure or surgery
- •left atrium diameter > 50mm
- •presence of intracardiac thrombus
- •Left ventricular ejection fraction < 40%
- •Heart failure class III-IV
- •Severe valvulopathies
- •Acute coronary syndrome or cardiac surgery within the previous 3 months of enrollment
- •Transient ischemic attack/stroke within the previous 6 months of enrollment
- •life expectancy less than 1 year
- •Any contraindication to the procedure according to the current clinical practice
研究组 & 干预措施
Control Arm
Conventional protocol for cryoablation:
At least 2 applications of 180s each
干预措施: Conventional cryotherapy dosage (Other)
Control Arm
Conventional protocol for cryoablation:
At least 2 applications of 180s each
干预措施: Arctic Front Advance ST Cryoenergy Balloon Catheter (Device)
Control Arm
Conventional protocol for cryoablation:
At least 2 applications of 180s each
干预措施: Adenosine triphosphate (Drug)
Control Arm
Conventional protocol for cryoablation:
At least 2 applications of 180s each
干预措施: nECG platform Nuubo® (Device)
Study Arm
Experimental protocol for cryoablation:
Time to effect + 1 minute and a bonus application of 120s
干预措施: Experimental cryotherapy dosage (Other)
Study Arm
Experimental protocol for cryoablation:
Time to effect + 1 minute and a bonus application of 120s
干预措施: Arctic Front Advance ST Cryoenergy Balloon Catheter (Device)
Study Arm
Experimental protocol for cryoablation:
Time to effect + 1 minute and a bonus application of 120s
干预措施: Adenosine triphosphate (Drug)
Study Arm
Experimental protocol for cryoablation:
Time to effect + 1 minute and a bonus application of 120s
干预措施: nECG platform Nuubo® (Device)
结局指标
主要结局
Atrial fibrillation-free survival, without antiarrhythmic drug therapy
时间窗: 12 months
次要结局
- Acute reconnection of pulmonary veins(Intraprocedure)
- Total cryotherapy time(Intraprocedure)
- Total procedure time(Intraprocedure)
- Time required to complete isolation of all the pulmonary veins (LA time)(Intraprocedure)
- Mean number of cryotherapy applications per patient to complete isolation(Intraprocedural)
- Atrial fibrillation burden detected by Nuubo system(12 Months)
- Adverse events(Intraprocedure)
- Total number of atrial fibrillation episodes monitored by Nuubo system(12 Months)
- Total time in atrial fibrillation monitored by Nuubo system(12 months)
研究者
Angel Ferrero
MD-PhD
Fundación para la Investigación del Hospital Clínico de Valencia