NCT05411614招募中不适用
A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure
St. George's Hospital, London7 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications
研究概览
简要总结
A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and Heart Failure
详细描述
The objective of this randomized study is to evaluate the safety and efficacy of Convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal AF and heart failure.
Patients will be randomised in a 1:1 ratio. The primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months (12 and 24 months).
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
- Single (Outcomes Assessor)
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
- •Persistent or Long-standing Persistent AF
- •Dilated left atrium (at least moderately dilated)
- •Suitable for either procedure
- •LVEF < 50%
排除标准
- •Not yet optimised from a medical or lifestyle perspective for AF or heart failure
- •Unable to provide written consent
- •Previous open-heart surgery
- •Active infection, oesophageal ulcer stricture or oesophageal varices
- •Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable)
- •Contraindication to anticoagulation, or active thrombus in the left atrium despite therapeutic anticoagulation
- •Severe valvular heart disease
- •Unstable coronary artery disease
- •Uncontrolled ventricular arrhythmia
- •Heart attack or stroke within the last 90 days
- •Pregnant, breastfeeding, or women of childbearing age who plan to get pregnant within six months
- •Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures
结局指标
主要结局
Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications
时间窗: Measured from the end of a 3-month blanking period at 12 and 24 months
Recurrence of persistent atrial arrhythmia during follow-up months).
次要结局
- Safety Endpoint(Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure)
- Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications(Measured from the end of a 3- month blanking period at 12 and 24 months)
- Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)(Measured from the end of a 3- month blanking period at 12 and 24 months)
- To assess left ventricular structural remodelling and change in ventricular function in response to either procedure(Pre-procedure and at 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score)(Pre-procedure and at 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class).(Pre-procedure and at 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's quality of life (EQ5D)(Pre-procedure and at 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's quality of life (AFEQT)(Pre-procedure and at 12 and 24 months post-procedure)
- To assess left atrial remodelling in response to either technique.(Pre-procedure and up to 12 and 24 months post-procedure)
- Safety Endpoint(Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure)
- Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications(Measured from the end of a 3- month blanking period at 12 and 24 months)
- Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)(Measured from the end of a 3- month blanking period at 12 and 24 months)
- To assess left ventricular structural remodelling and change in ventricular function in response to either procedure(Pre-procedure and at 12 and 24 months post-procedure)
- To assess left atrial remodelling in response to either technique.(Pre-procedure and up to 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score)(Pre-procedure and at 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class).(Pre-procedure and at 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's quality of life (EQ5D)(Pre-procedure and at 12 and 24 months post-procedure)
- To evaluate the effects of the interventions on the patient's quality of life (AFEQT)(Pre-procedure and at 12 and 24 months post-procedure)
研究者
Riyaz Kaba
Consultant in Cardiology and Cardiac Electropysiology
St. George's Hospital, London
研究点 (7)
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