Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
研究概览
简要总结
The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.
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 (Participant)
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
- •Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
- •Non-paroxysmal atrial fibrillation, as pre-classified as
- •Persistent AF: AF requiring Electrical/ Chemical cardioversion or that lasting >7 days. These patients may be in AF or in sinus Rhythm at the time of their initial assessment and/ or at the time of their ablation.
- •Continuous Persistent AF: These patients are persistently in AF with or without antiarrhythmic drug therapy, as confirmed on a 24 hour Holter. They may have undergone previous cardioversion(s).
- •Sustained Paroxysmal AF with underlying substrate: Patients with Individual AF episode(s) lasting >12 hours but less than 7 days plus one or more of the following:
- •Age >65 years 21
- •Individual AF episode(s) lasting >24 hours
- •Significant left atrial dilatation of >45 mm on Echo (Parasternal Long Axis view)
- •Obesity (Body Mass Index >30), and/ or history suggestive of sleep apnoea
- •Diabetes Mellitus requiring hypoglycaemic drugs and/or Insulin
排除标准
- •Inability or unwillingness to receive oral anticoagulation with warfarin
- •Previous Ablation procedure for AF
- •Unwillingness or inability to complete the required follow up arrangements
- •Presence of long standing persistent AF with continuous AF longer than 12 months. This includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
- •Documented typical atrial flutter
- •Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
- •Contraindications and/ or prior intolerance to both Amiodarone and Flecainide.
- •Reversible cause for atrial fibrillation
- •Known hypertrophic or infiltrative cardiomyopathy
研究组 & 干预措施
Pulmonary vein isolation
Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
干预措施: Pulmonary vein isolation (PVI) (Procedure)
Pulmonary vein isolation
Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
干预措施: Pharmacological Substrate modification (Drug)
Pulmonary vein isolation + Linear Lesions
Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
干预措施: Pulmonary vein isolation + linear lesions (Procedure)
Pulmonary vein isolation + Linear Lesions
Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
干预措施: Pharmacological Substrate modification (Drug)
结局指标
主要结局
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
时间窗: 12 months
Defined as \>30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.
次要结局
未报告次要终点
研究者
Dhiraj Gupta
Consultant Cardiologist
Liverpool Heart and Chest Hospital NHS Foundation Trust