Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- AF recurrence
研究概览
简要总结
Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.
详细描述
the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation:
- Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment.
- Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation.
- Left atrial catheter ablation.
These treatment options have not been directly compared and each has their own advantages and disadvantages.
- DC cardioversion is highly successful at restoring sinus rhythm and is a relatively cheap intervention. There is however a high recurrence rate of AF and cardioversion may need to be repeated multiple times.
- Permanent pacemaker implantation and AV node ablation, 'ablate and pace' therapy provides rapid relief of symptoms and improved quality of life. Patients remain in atrial fibrillation but have a regular heart rhythm and controlled rate and avoid potential side-effects of medications. Following AV node ablation patients are dependent on the pacemaker and as such this treatment option is usually reserved for those over 65 years or age. Costs are modest and both the pacemaker insertion and AV node ablation procedures take less than 1 hour to perform.
- Catheter ablation for atrial fibrillation aims to restore and sustain sinus rhythm. Procedural success rates are 50-60% after a single procedure and 80-85% after repeat procedures and it can take several months for all procedures in an ablation strategy to be performed. Procedural costs are high due to the equipment used and time taken for each ablation, usually 1.5-4 hours.
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 with symptomatic persistent atrial fibrillation of less than 1-year duration.
- •Patients must be over 65 years old.
- •Patients give informed consent prior to participating in this study.
排除标准
- •Paroxysmal atrial fibrillation.
- •Long-standing persistent or permanent atrial fibrillation.
- •Previous pacemaker implantation.
- •Previous atrial ablation.
- •Patient is unable to take warfarin or other oral anti-coagulant medication.
- •Patient is suffering with unstable angina in last one week.
- •Patient has had a myocardial infarction within last two months.
- •Patient is expecting or has had major cardiac surgery within last two months.
- •Patient is participating in a conflicting study.
- •Patient is unable to perform exercise testing.
- •Patient is mentally incapacitated and cannot consent or comply with follow-up.
- •Patient has New York Heart Association (NYHA) class III/IV heart failure.
- •Patient has left ventricular ejection fraction (LVEF) less than 35% not secondary to tachycardia.
- •Pregnancy.
- •Patient suffers with other cardiac rhythm disorders.
- •Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
研究组 & 干预措施
Catheter Ablation
Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder.
干预措施: Catheter ablation (Procedure)
Catheter Ablation
Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder.
干预措施: Implantable loop recorder (Device)
Pacemaker and AV node ablation
Participants will have a permanent pacemaker implant followed by AV node ablation
干预措施: Pacemaker and AV node ablation (Procedure)
DC cardioversion
Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder.
干预措施: DC Cardioversion (Procedure)
DC cardioversion
Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder.
干预措施: Implantable loop recorder (Device)
结局指标
主要结局
AF recurrence
时间窗: 12 months
Time to recurrence of persistent AF
次要结局
- Sleep apnoea(6 months)
- Exercise performance(12 months)
- Patient experience of procedure(Baseline)
- AF recurrence >2minutes(12 months)
- Symptoms / QOL(12 months)
- AF burden(12 months)
- Total costs of the treatment options(12 months)
研究者
Rick Veasey
Consultant Cardiologist
Eastbourne General Hospital