Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Return to sinus rhythm rate
研究概览
简要总结
Rationale: To determine the most beneficial ablation methodology for individual patients with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place the epicardial and endocardial ablation lines.
Objectives: Catheter and surgical ablation are being offered today to patients with drug refractory and symptomatic atrial fibrillation. This study is designed to assess the most efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation. In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.
Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at 6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.
We hypothesize that the safety of all procedures will show no differences and that there will be no differences in clinical complications between groups.
详细描述
Study Type: This is an experimental study in which patients who present with either paroxysmal or persistent atrial fibrillation will be randomized based on their left atrial size (≤ 5.0 or > 5.0 but < 6.1 cm) to receive a hybrid ablation approach vs percutaneous catheter where in both procedures ablation will include pulmonary vein isolation with a left and right atrial flutter line for patients with a left atrium ≤ 5.0 cm. and hybrid approach will be compared to the Cox Maze III procedure for patients with a left atrium > 5.0 < 6.1 cm .
Study Design: One hundred and fifty two patients (n=152) with persistent or paroxysmal atrial fibrillation who present for surgical or catheter ablation intervention are to be enrolled. The study will take place at the Inova Heart and Vascular Institute in Falls Church, VA in the specially designed hybrid surgical suite in the cardiovascular operating area. We expect enrollment to take (two years study duration). Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume). Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society, require other cardiac surgery, are unable to take anticoagulation or require prescribed anti arrhythmic medication for reason other than atrial fibrillation, have a left atrium measuring greater than 6.0 cm (volume),have had previous catheter ablation for atrial fibrillation (Do not exclude for prior AVNRT) or a pacemaker, are less than 18 years of age, are unable or unwilling to be followed according to set protocol to include implantation of a heart monitor 6 weeks prior to their ablation procedure.
Study Methodology: This is an experimental study in which patients who present with either paroxysmal or persistent atrial fibrillation will be randomized based on their left atrial size.
For patients with a left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines. In the group of patients with left atrial size of 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure (Figure 1). Each patient regardless of procedure will have their left atrial appendage closed. All patients will receive an internal event monitor (Reveal XT) which will be placed 6 weeks before their procedure to establish atrial fibrillation burden. All patients will also be given a health related quality of life and a symptom frequency and severity tool to fill out prior to their ablation and at 3 and 6 months post ablation.
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months and atrial fibrillation burden
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
- •Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume)
- •Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms
- •Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset
- •Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to include medication therapy and/or electric cardioversion
排除标准
- •Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society
- •All patients with MV +2 mitral regurgitation will be excluded
- •Require other cardiac surgery procedures will be excluded
- •Are unable to take anticoagulation
- •Are unable to take any prescribed anti arrhythmic medication
- •Have a left atrium measuring greater than 6.0 cm (volume)
- •Have had previous catheter ablation for atrial fibrillation
- •Have had previous pace maker implantation
- •Are less than 18 years of age
- •Do not speak English and no translation can be provided
- •Are unable or unwilling to be followed according to set protocol to include obtaining an internally heart monitor 6 weeks prior to their ablation procedure
结局指标
主要结局
Return to sinus rhythm rate
时间窗: 2-3 years
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months.
次要结局
- Post procedure morbidities(up to 6 months post procedure)