Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Percentual success of the procedure during the hospitalization
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.
详细描述
No more available data
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
- •Both sexes; age>18 yrs
- •ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter.
- •No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
- •Patients willing to accept the tests and to follow standard procedures
- •Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment
排除标准
- •Atrial fibrillation
- •Any arrhythmia requiring antiarrhythmics in the 6 months post procedure
- •Intra atrial thrombosis
- •NYHA class IV
- •Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month
- •Untreated Wolf Parkinson White syndrome
- •Contraindications to oral anticoagulation
- •Life expectancy < 12 month
- •Major surgery or interventional procedure already planned in the 6 month following ablation
- •Pregnancy or breast-feeding
- •Participation in another study
结局指标
主要结局
Percentual success of the procedure during the hospitalization
时间窗: Up to 4 days
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 3 months from procedure
时间窗: 3 months
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 6 months from procedure
时间窗: 6 months
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
次要结局
- •Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.(Up to 4 days; 3-6 month)
- Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given(Up to 4 days)
- Safety of the procedure(Up to 4 days)