A Comparison of Isolating the Pulmonary Veins With the Cryoballoon Catheter Versus Radiofrequency Segmental Isolation:a Randomized Controlled Prospective Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 2
- 主要终点
- Combined Endpoint Out of: Absence of Atrial Arrhythmias and Absence of Persistent Complications at Six Months After the Index Procedure
研究概览
简要总结
This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be compared to the standard ablation technique (segmental isolation of the pulmonary veins) with radiofrequency energy. The primary study aim is to investigate whether the new cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of atrial arrhythmias without persistent complications after six and twelve months. Furthermore, the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during the procedure, levels of cardiac inflammatory markers are compared between the treatment groups. The short and long-term clinical success as well as the costs of both systems will also be evaluated.
详细描述
Study objectives:
This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be compared to the standard ablation technique (segmental isolation of the pulmonary veins) with radiofrequency energy. The primary study aim is to investigate whether the new cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of atrial arrhythmias without persistent complications after six and twelve months. Furthermore, the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during the procedure, levels of cardiac inflammatory markers are compared between the treatment groups. The short and long-term clinical success as well as the costs of both systems will also be evaluated.
Brief description of the cryoablation:
This catheter system uses nitrous oxide as refrigerant to cool the inside of the catheter tip or the balloon down to -30 to -70 degree in a closed system. Delivering the freezing energy on human cells for several minutes leads to their destruction. The destructed cells cannot conduct anymore. For PV isolation the cryoballoon can be placed at the orifice of the pulmonary veins to ablate the muscle connections between the PV- and left atrium (LA).
Study background:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented paroxysmal PAF: PAF diagnosis, 2 episodes of PAF within the last 3 months, at least 1 episode of PAF must be documented.
- •Age 18-75
- •Documented effectiveness failure of at least 1 AAD including beta-blockers
排除标准
- •AAD usage < 3 half life periods (except beta-blocker)
- •LA size > 55 mm
- •LA thrombus
- •Previous LA ablation/surgery, structural heart disease, heart failure class III-IV
- •Hypertrophic cardiomyopathy
- •Mitral prosthesis
- •Unstable angina
- •Uncontrolled hyperthyroidism
- •Stroke or TIA within 6 months
- •Myocardial infarction within 2 months
- •Cardiac surgery within 3 months
- •Thrombocytosis, thrombocytopenia
- •Any condition contraindicating chronic anticoagulation
- •EF < 40%
- •Pregnancy
- •Life expectancy < 1 year
结局指标
主要结局
Combined Endpoint Out of: Absence of Atrial Arrhythmias and Absence of Persistent Complications at Six Months After the Index Procedure
时间窗: Six months after procedure
Redo procedures were only allowed after the 6 month follow up. Redo procedures had to be performed using the same energy source. No ADD administration was allowed after the ablation procedure.
Combined Endpoint Out of: Absence of Atrial Arrhythmias and Absence of Persistent Complications Twelve Months After Procedure.
时间窗: Twelve month after the procedure
Including redo procedures. Redo procedures were only allowed after the 6 month follow up. Redo procedures had to be performed using the same energy source. No ADD administration was allowed after the ablation procedure.
次要结局
- Long-term Clinical Success(Twelve month after the procedure)
- Total Radiation Exposure(at time of the procedure)
- Total Procedure Duration(at time of the procedure)
- Major Adverse Events(procedure date till 12 month after the procedure)
- Mid-term Clinical Success(Six month after the procedure)
研究者
Armin Luik, MD
Dr. Armin Luik
Staedtisches Klinikum Karlsruhe