Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Total cumulative radio frequency (RF) delivery time
研究概览
简要总结
Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:
- guided by contact force sensing (CFS) OR
- blinded to contact force sensing (CFS) - i.e. standard approach
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Patients undergoing first-time catheter ablation for AF.
- •Persistent AF defined as episodes greater than 7 days duration.
- •Symptomatic AF defined as patients who have been aware of their AF anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
- •At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment.
- •Willing and able to provide informed consent.
排除标准
- •Paroxysmal AF.
- •AF secondary to a reversible cause.
- •Patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor.
- •Patients who have previously undergone AF ablation.
- •Patients with left atrial size >55 mm (echocardiography, parasternal long axis view).
- •Patients who are or may potentially be pregnant.
研究组 & 干预措施
Contact Force Sensing (CFS) Blinded
Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)
干预措施: ThermoCoolSmartTouch ablation catheter, Biosense Webster (Device)
Contact Force Sensing (CFS) Guided
Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)
干预措施: ThermoCoolSmartTouch ablation catheter, Biosense Webster (Device)
结局指标
主要结局
Total cumulative radio frequency (RF) delivery time
时间窗: 12 months
Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)
次要结局
- Freedom from AF or atrial arrhythmia >30 sec(12 months)
- Ability to achieve PV isolation with a single ring of lesions around each PV(6 hours)
- Ability to achieve linear ablation with complete conduction block on the first attempt(6 hours)
- Number & location of conduction gaps after initial circumferential ablation lines(6 hours)
- Number & location of conduction gaps after initial linear ablation(6 hours)
- Time required for successful PV isolation(12 months)
- Total fast anatomical mapping (FAM) time(12 months)
- Time required for successful linear ablation(12 months)
- FAM volume(12 months)
- Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis(90 days)
- Incidence of repeat ablation procedures(12 months)
- Incidence of conduction gaps around pulmonary veins(12 months)
- Freedom from atrial arrhythmia > 30 sec(12 months)
- Freedom from atrial arrhythmia > 30 sec after one or two procedures(12 months)
- Reduction in atrial arrhythmia burden by >90%(12 months)
研究者
Atul Verma
Principal Investigator
Southlake Regional Health Centre