FIRE AND ICE II Trial Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 10
- 主要终点
- Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure)
研究概览
简要总结
The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).
详细描述
60 patients with persistent AF will be randomized 1:1 between Cryoballoon ablation and Radiofrequency ablation in the FIRE AND ICE II Trial Pilot at 5 clinical sites in Europe.
The data collected within the pilot phase will be reviewed and a decision on extending the trial with an extended number of patients and sites as main phase will be taken.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Single-blinded; participants will be blinded to the treatment group. Investigators will be blinded on study specific diagnostics used in the trial; Endpoint Review Committee will be blinded to the treatment group.
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
- •Documentation of symptomatic persistent AF (following the European Society of Cardiology (ESC) guideline 2016) defined as: Persistent AF - AF that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more
- •Date of first diagnosis of persistent AF within the last 12 months preceding the date of screening
- •Documented treatment failure or intolerance of at least one Class I or Class III antiarrhythmic drug
排除标准
- •Known pre-existing hemi-diaphragmatic paralysis
- •Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- •History of right atrial flutter, not ablated prior to enrollment
- •Any cardiac surgery, myocardial infarction, percutaneous coronary intervention or coronary artery stenting which occurred within the 3 months before the eligibility assessment
- •Unstable angina pectoris
- •Primary pulmonary hypertension
- •Any condition contraindicating chronic anticoagulation
- •Any cerebral ischemic event (stroke or transient ischemic attack [TIA]) which occurred within the 6 months before the consent date
- •Presence of any cardiac prosthetic valves
- •Long-standing persistent AF lasting for ≥ 1 year (even when it is decided to adopt a rhythm control strategy)
- •New York Health Association (NYHA) class III or IV heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measured by acceptable cardiac testing (e.g. TTE)
- •Acute cardiac condition, including endocarditis, pericarditis or pericardial effusion
- •Presence or likely implant of a permanent pacemaker, biventricular pacemaker or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
结局指标
主要结局
Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure)
时间窗: 12 Month
To demonstrate that Cryo ablation is non-inferior to radiofrequency (RF) ablation with respect to time to clinical treatment failure, defined as recurrence of atrial arrhythmias or intervention for AF (a blanking period of three months will be maintained after the index procedure). The first documented recurrence of an episode of atrial arrhythmia after the blanking period lasting at least 30 seconds will be counted for the primary efficacy objective, as well as any intervention for AF with initiation after the blanking period.
Safety Objective (freedom from device and procedure related serious adverse events (SAEs))
时间窗: 12 Month
To demonstrate that Cryo ablation is non-inferior to RF ablation with respect to freedom from device and procedure related serious adverse events (SAEs). The first device or procedure related serious adverse event with onset after start of the index ablation therapy will be used for the safety objective analysis.
次要结局
- Evaluate post-procedural interventions for atrial arrhythmias(12 Month and 36 Month)
- Assess quality of life: EQ-5D-5L(12 Month and 36 Month)
- Characterize AF burden data seen on Reveal LINQ in subjects with any post-procedural intervention for AF(12 Month and 36 Month)
- Evaluate the relation between outcome and AF burden in the 4 weeks before ablation (Reveal LINQ will be assessed)(3 Month)
- Assess acute procedural success (PVI)(3 Month)
- Evaluate incidence rate of post-procedure events(12 Month and 36 Month)
- Characterize AF burden seen on Reveal LINQ(12 Month and 36 Month)
- Comparison of the lesion area as measured by cardiac MRI at Month 3(3 Month)