Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
研究概览
简要总结
Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left atrial flutter1 inducible during electrophysiological evaluation.
- •Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.
- •Informed consent.
- •Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above.
排除标准
- •Previous ablation of LAFL.
- •Previous linear ablation in the LA except for pulmonary vein isolation.
- •Absolute contraindication for oral anticoagulation.
- •Stroke or acute coronary syndrome less than 3 months before ablation.
- •Complex congenital heart disease.
研究组 & 干预措施
High-density mapping guided ablation
High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation.
干预措施: Radiofrecuency ablation (Other)
Empirical linear ablation
Empirical predefined set of linear ablation.
干预措施: Radiofrecuency ablation (Other)
结局指标
主要结局
Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
时间窗: 1 year follow-up
Daily 1-lead 30 seconds ECG samples.
次要结局
- Safety.(Acute a 1 month after ablation (procedure-related complications).)
- Acute success.(Acute intraprocedural.)
- Non-inducibility.(Acute intraprocedural.)
- Hospitalization.(1 year.)
- Procedure duration.(Acute intraprocedural.)
- Left atrial dwell time.(Acute intraprocedural.)
研究者
Dr. Sergio Castrejón-Castrejón
Electrophysiologist, Principal investigator (togheter with Dr. José Luis Merino)
Hospital Universitario La Paz