Real-time Automated Program for IDentification of VT Origin - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Non-inducibility of VT
研究概览
简要总结
RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.
详细描述
Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration.
During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites.
Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of:
- •Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and
- •One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug:
- •A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD
排除标准
- •Patients will be excluded from the trial if they:
- •Are unable or unwilling to provide informed consent.
- •Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization.
- •Are antiarrhythmic drug-naïve.
- •Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves.
- •Have had a prior catheter ablation procedure for VT.
- •Are in renal failure (Creatinine clearance <15 mL/min)
- •Have NYHA Functional class IV heart failure or CCS Functional class IV angina.
- •Have had recent ST elevation myocardial infarction (< 1 month).
- •Are pregnant or have a systemic illness likely to limit survival to <1 year.
研究组 & 干预措施
RAPID-VT Software guided ablation
The induced VT(s) 12-lead ECG will be acquired by the RAPID-VT software which will provide real time localization of the VT(s) exits from the scar margin. These exits will be targeted by ablation
干预措施: RAPID-VT Software guided ablation (Other)
结局指标
主要结局
Non-inducibility of VT
时间窗: At end of ablation procedure
Lack of any inducible VT at the end of the ablation procedure
次要结局
- Procedure efficacy measure: VT(s) ablated(At end of procedure)
- Procedure safety measure: Acute complications(At end of procedure and at 30 days of follow up)
- Procedure efficacy measure: VT recurrence(During follow up period of 6 months)
- Procedure safety measure: Clinical heart failure worsening(At end of procedure, at 30 days and 6 months of follow up)
- Procedure efficacy measure: Procedure duration(At end of procedure)
- Procedure safety measure: Mortality and hospitalization for cardiac causes(At 30 days and 6 months of follow up)
研究者
Amir AbdelWahab
Attending Cardiac Electrophysiologist, Associate Professor of Medicine, Division of Cardiology, Department of Medicine
Nova Scotia Health Authority