Individualized Approach vs. Fixed Approach Utilizing the Novel Arctic Front Advanced Pro Cryoballoon for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Freedom from documented atrial tachyarrhythmia (every documented episode of atrial tachyarrhythmia lasting >/=30 seconds will be count as recurrence.
研究概览
简要总结
The purpose of the current study is to assess differences regarding the acute efficacy, safety, procedural duration, radiation exposure and long-term success of the novel AFA-Pro in combination of an individualized shortened ablation protocol containing a reduced freezing time to the standard approach of a fixed ablation protocol in patients with symptomatic PAF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •The patient understands the nature of the study, treatment procedure and provides written informed consent
- •Symptomatic paroxysmal atrial fibrillation as defined by the current guidelines
- •Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
- •Expected to remain available (geographically stable) for at least 12 months after enrollment
排除标准
- •Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- •Previous AF ablation procedure
- •Longstanding persistent AF
- •Documented left atrial thrombus on imaging (e.g., transesophageal echocardiogram, angiogram)
- •NYHA functional Class IV heart failure
- •Unstable angina
- •Left ventricular ejection fraction < 30%
- •Valvular disease requiring interventional treatment
- •Cardiac surgery within 3 months prior to enrolment
- •Left atrial size > 55 mm as measured in the parasternal antero-posterior view
- •Uncontrolled bleeding, diathesis, coagulopathy or pro-coagulant state
- •Active systemic infection or sepsis
- •Other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.
结局指标
主要结局
Freedom from documented atrial tachyarrhythmia (every documented episode of atrial tachyarrhythmia lasting >/=30 seconds will be count as recurrence.
时间窗: Month 12
The primary endpoint of the current study is freedom from documented atrial tachyarrhythmia (\>/=30 seconds) documented by ECG 4-12 months after PVI off antiarrhythmic drugs. Atrial tachyarrhythmias comprise AF as well as atrial tachycardia and atrial flutter. Holter-ECGs as well as 12-lead ECGs will be conducted. Every epsiode of documented atrial tachyarrhythmia (\>/=30 seconds)outside the blanking period will count as "recurrence".
次要结局
- Acute procedure success(Day 0)
- Radiation exposure of patient and operator(Day 0)
- Number of freeze-cycles to achive pulmonary vein isolation.(Day 0)
- Procedure duration(Intraoperative)
- Duration of freeze-cycles to achive pulmonary vein isolation(Day 0)
- Radiation exposure duration(Day 0)
- Periprocedural complications(Day 0)
研究者
Christian-H. Heeger, MD
Consultant Rhythmology
University of Luebeck