Surgical Ablation of AF Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Number of hospital readmissions for heart failure over duration of follow-up
研究概览
简要总结
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
详细描述
Atrial fibrillation (AF) affects more than 1% of the general population and is an important risk factor for stroke. AF prevalence increases with age, occurring in 10 to 15% of patients older than 80 years of age, which is important with the aging population. Of patients undergoing cardiac surgery, 10.8% have a history of AF. AF is believed to cause the left atrium to dilate and lose its transport function. AF significantly increases the risk of ischemic stroke of cardioembolic origin, but is also associated with heart failure and impairs quality of life. Although the causal relationship between the 2 clinical entities has not been fully elucidated, AF is believed to cause heart failure via several mechanisms.
Ablation of AF is the application of scars to the atrial tissue to disrupt faulty electrical signals that cause the arrhythmia. If surgical ablation of AF yields a benefit similar to catheter-based AF ablation, thousands of people undergoing cardiac surgery could benefit from this procedure each year. SAFE will be a landmark trial in cardiac surgery, definitely establishing surgical AF ablation's impact on cardiovascular outcomes. Cardiac surgery is the optimal setting to establish whether maintenance of sinus rhythm through AF ablation yields clinical benefit, and is a setting where sham-control is possible. This will not only provide evidence for the cardiac surgical patients but will bolster the evidence for ablation (catheter or stand-alone surgical) in other AF patients.
The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation. The primary outcome is hospital readmissions with heart failure during 4 years of follow-up. This study will enroll 2000 patients from 50 centres, globally. Patients will be followed at hospital discharge, 4 to 6 weeks after surgery, 6 months after surgery, and then at 6-month intervals until the final follow-up visit, for a median follow-up for 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding to allocation will be maintained for all parties, excluding the operating surgeon and necessary operating room personnel.
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
- •Age ≥ 18 years;
- •Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof;
- •Documented history of paroxysmal or persistent AF
- •Provide informed consent
排除标准
- •Dominant atrial arrhythmia is atrial flutter;
- •Documented left atrial diameter ≥ 6 cm;
- •Previous cardiac surgery requiring opening of the pericardium;
- •Patients undergoing any of the following procedures:
- •Heart transplant
- •Complex congenital heart surgery
- •Sole indication for surgery is ventricular assist device insertion
- •Mitral valve repair or replacement
- •Tricuspid valve repair or replacement
- •Patient resides in a long-term care facility
结局指标
主要结局
Number of hospital readmissions for heart failure over duration of follow-up
时间窗: Common termination point for trial (median follow-up of 4 years)
Total number of hospital readmissions for heart failure.
次要结局
- Antiarrhythmic drug use(Beyond 6 weeks until common termination point for trial (median follow-up of 4 years))
- All-cause mortality(Common termination point for trial (median follow-up of 4 years))
- Freedom from recurrence of atrial tachyarrhythmia(1 year post-operatively)
- Quality of Life - atrial fibrillation specific(At 1 year, and at common termination point for trial (median follow-up of 4 years))
- Number of Ischemic stroke or systemic arterial embolism events over duration of follow up(Common termination point for trial (median follow-up of 4 years))
- Length of ICU stay(From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years))
- Length of hospital stay(From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years))
- Cardiovascular mortality(Common termination point for trial (median follow-up of 4 years))
- Number of patients undergoing atrial fibrillation ablation(90 days post- study surgery until common termination point for trial (median follow-up of 4 years))
- Quality of Life - heart failure specific(At 1 year, and at common termination point for trial (median follow-up of 4 years))
- Quality of Life - General(At 1 year, and at common termination point for trial (median follow-up of 4 years))
- Number of days free from admission to healthcare facility or presentation to the emergency department for heart failure(Common termination point for trial (median follow-up of 4 years))
研究者
Richard Whitlock
Professor of Surgery
Population Health Research Institute