REVOLUTIONARY Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Efficacy - Freedom from Arrhythmia
研究概览
简要总结
describe real-world adaption, work-flow data as well as procedural and follow-up outcomes after balloon-in-basket guided PFA for AF in early European users.
详细描述
A prospective, multi-center registry, REal-world Valued Outcomes of a noveL balloon-in-basket pUlsed field ablaTION catheter for Atrial fibrillation RegistrY - the REVOLUTIONARY Registry - was designed. All-comer data of patients with symptomatic atrial fibrillation (AF) who underwent catheter ablation using the novel balloon-in-basket PFA catheter will be collected from European high-volume centers who were involved in the early market release of the VOLT (Abbott) technology. Data includes patient demographics, procedural metrics on safety and efficacy as well as follow-up outcome data. Learning curve characteristics and comparison on different workflows will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients who underwent an AF catheter ablation procedure using the novel balloon-in-basket VOLT PFA system will be included into the analysis.
- •Age ≥ 18 years
- •Subject is able and willing to give informed consent
排除标准
- •LA-Diameter > 60mm
- •Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement
- •Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator
- •Known intra-cardiac thrombus formation Any contraindication for oral anticoagulation
- •Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism
- •Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control
- •Active systemic infection
研究组 & 干预措施
single arm
single arm registry
干预措施: PFA Ablation (Procedure)
结局指标
主要结局
Efficacy - Freedom from Arrhythmia
时间窗: 12 month
Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period.
次要结局
- Adverse Events(12 Months)
- Procedural efficacy(12 Months)
研究者
Boris Schmidt
Prof. Dr. med.
Cardioangiologisches Centrum Bethanien