Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation - A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Single procedure success rate at 12 months
研究概览
简要总结
Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. It is a complex procedure to perform so only a few hospitals are able to offer this treatment in the UK. A new technology allows the operator to guide their catheters (thin wires) in the patient by using a robotically steered sheath. This allows accurate and precise navigation that may improve the accuracy and integrity of ablation. We aim to prove whether this technology can make AF ablation easier and more effective.
Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.
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
- •All patients with symptomatic AF planned for catheter ablation.
排除标准
- •Age < 18 years
- •Previous ablation procedure
- •Expected life expectancy < 6 months
- •Inability or unwillingness to sign consent
- •Pregnancy
- •Contraindications for the ablation procedure o Thrombus in the left atrium that fails to resolve with optimal oral anticoagulation therapy
结局指标
主要结局
Single procedure success rate at 12 months
时间窗: 12 months
次要结局
- Platelet substudy: Platelet activation post ablation compared to baseline.(3 months)
- Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue(0-12 months)