Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 172
- 主要终点
- All cause rehospitalisation
研究概览
简要总结
The goal of this clinical trial is to compare two procedural approaches to managing atrial fibrillation. The main questions it aims to answer are:
Is AF ablation or pacemaker implant and AV nodal ablation a more effective treatment approach for patients with atrial fibrillation refractory to pharmacological treatment?
What effect do these differing treatment approaches have on patient's quality of life and mental health?
Participants will:
Be randomly allocated to one of the treatment approaches. Visit the clinic 2 months, 12 months and 24 months after their procedure for a checkup, questionnaires and repeat heart ultrasounds.
详细描述
The goal of this trial is to compare the effectiveness and safety of pulmonary vein isolation compared with pacemaker implant and atrioventricular nodal ablation for patients with atrial fibrillation.
Patients who have been refractory to attempts at symptom control with pharmacological therapy will be eligible and will be randomised to one of the two approaches.
The primary outcome will be all cause rehospitalisation with secondary outcomes including procedural complications, echocardiographic measurements, patient reported outcomes, all cause mortality and rehospitalisation due to cardiovascular causes. These will be assessed over the 2 years following the index procedure.
The patient reported outcome measures will be the EQ5D, AF Effect on Quality of life score (AFEQT), Hospital anxiety and depression score (HADS) and Somatosensory amplification scale.
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
- •Age greater than 65 years for patients with persistent atrial fibrillation or greater than 75 years for patients with paroxysmal atrial fibrillation.
- •Unsuccessful trial of at least one pharmacological rate or rhythm control medication. This includes patients with medication refractory AF and/or intolerance to the medication(s).
- •A resting ECG demonstrating AF with ventricular response rate >70bpm on a pharmacological rate control medication, or >90bpm while not on rate control medication.
排除标准
- •Previous pulmomary vein isolation, left atrial flutter ablation or atrioventricular node ablation.
- •Not suitable for pulmonary vein isolation and/or pacemaker implant on clinical grounds.
结局指标
主要结局
All cause rehospitalisation
时间窗: 2 years
All rehospitalisations for any reason will be included
次要结局
未报告次要终点
研究者
Matthew Tung
Principal Investigator
Sunshine Coast Hospital and Health Service