Loop Recorder Evaluation in Patients Treated With High Power Short Duration Ablation for Paroxysmal Atrial Fibrillation With High Density Multi Directional Mapping (LOWE AF HD Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Acute Procedural Success Rate
研究概览
简要总结
The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.
详细描述
Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes:
- Multi-directional high-density mapping
- High power - short duration settings
- Contact force sensing ablation catheter The aim of LOWE AF HD is to assess the acute safety and success rate of this approach and also the long-term outcome assessed by atrial recurrences arrythmias collected by an implantable loop recorder.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal AF
- •18 Years and older.
- •Able and willing to provide written informed consent prior to any clinical investigation related procedure
- •Able and willing to complete all required study procedures through 12 months
- •Life expectancy less than 12 months
排除标准
- •Persistent or long-standing persistent AF
- •Presence of thrombus in left atrium and left atrium appendage
- •MI, CABG or PCI within preceding 3 months
- •Left atrial diameter > 5.0 cm
- •LVEF < 35%
- •NYHA class III or IV
- •Previous atrial fibrillation ablation procedure with high density and high-power short duration approach
- •Previous tricuspid or mitral valve repair surgery
结局指标
主要结局
Acute Procedural Success Rate
时间窗: 1 day
Acute procedural success defined as electrical isolation of all pulmonary veins, confirmed by the high-density voltage remap and loss of pace capture along ablation line after complete isolation.
Rate of patients without Atrial Fibrillation recurrences
时间窗: 12 months after 3-months blanking period
Freedom from Atrial Fibrillation (AF) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL), lasting longer than 30 second, assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR).
次要结局
- Number of radiofrequency applications(1 day)
- Ablation Procedure Time(1 day)
- Total radiofrequency ablation time(1 day)
- First pass pulmonary vein isolation(1 day)
- Number of atrial fibrillation events(12 months)
- Adverse events rate(1 month)
- Ablation Fluoroscopic Time(1 day)
- Atrial Fibrillation Burden(12 months)
研究者
Gregorio Covino
Principal Investigator
Ospedale S. Giovanni Bosco