Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
试验速览
- 阶段
- 不适用
- 入组人数
- 590
- 试验地点
- 23
- 主要终点
- Occurrence of the first appropriate ICD shock during phase A
研究概览
简要总结
The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.
详细描述
Enrolled patients will remain in a first phase of the study until the first appropriate ICD shock will be delivered.
The objective of this first stage is to assess whether the burden of untreated non sustained VTs or episodes treated with anti-tachycardia pacing is predictive of appropriate ICD shocks.
The second phase of the study will start after the first appropriate ICD shock delivered for VT.
Patients will be then randomized to immediate VT ablation or to standard treatment, meaning waiting until next arrhythmic storm to perform a VT ablation procedure.
The objective of this phase is compare the rate of worsening heart failure hospitalizations and deaths from any cause between the two groups.
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 (Outcomes Assessor)
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 already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death
排除标准
- •Phase A exclusion Criteria:
- •General contraindication to transcatheter ablation
- •Contraindication to antithrombotic therapy
- •Patients chronically treated with class I and III antiarrhythmic drugs
- •Phase B exclusion criteria:
- •Patients developing first occurrence of incessant VTs
- •Patients receiving a shock for first occurrence of clinically verified ventricular fibrillation
- •Patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy
结局指标
主要结局
Occurrence of the first appropriate ICD shock during phase A
时间窗: Event Driven
Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B
时间窗: Two Years
次要结局
- Number of patients showing VT recurrences during phase B(Two Years)
- Number of patients showing electrical storm (ES) recurrences during phase B(Two Years)
- Number of patients showing cardiac deaths during phase B(Two Years)
研究者
Paolo Della Bella
Director of Arrhythmia Department and Clinical Electrophysiology Laboratories
IRCCS San Raffaele