NCT02501005终止不适用
Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 163
- 试验地点
- 10
- 主要终点
- Time to first event comprising all-cause mortality, unplanned hospital admission for congestive heart failure and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)
研究概览
简要总结
The BERLIN VT study is designed to evaluate the impact of prophylactic ventricular tachycardia (VT) ablation on all-cause mortality and unplanned hospital admission for congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation (VF) when compared to VT ablation after the third appropriate implantable cardioverter-defibrillator (ICD) shock.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of remote myocardial infarction
- •Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment
- •Documentation of sustained ventricular tachycardia (VT) by any kind of Electrocardiography (ECG) including 12 lead ECG, holter ECG, rhythm strip, event monitoring, event recorder or pacemaker within 30 days before enrollment
- •Implantable cardioverter-defibrillator (ICD) indication for secondary prevention
- •Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device)
- •Patient has provided written informed consent
- •Patient accepts activation of Home Monitoring®
排除标准
- •Age < 18 years or > 80 years
- •Known arterial or venous thrombosis
- •Class IV New York Heart Association (NYHA) heart failure
- •Valvular heart disease or mechanical heart valve precluding access to the left ventricle
- •Acute myocardial reinfarction or acute coronary syndrome
- •Cardiac surgery involving cardiotomy within the past 2 months
- •Patients requiring chronic renal dialysis
- •Thrombocytopenia or coagulopathy
- •Incessant VT or electrical storm
- •Bundle branch reentry tachycardia as the presenting VT
- •Pre-existing implantable cardioverter-defibrillator (ICD)
- •Pregnancy or breast feeding women
- •Acute illness or active systemic infection
- •Other disease process likely to limit survival to less than 12 months
- •Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study
- •Unwillingness to participate or lack of availability for follow-up
- •Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.
研究组 & 干预措施
Treatment Group 1 (TG1)
Experimental
Prophylactic VT ablation prior to ICD implantation
干预措施: VT ablation (Procedure)
Treatment Group 2 (TG2)
Other
ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter
干预措施: VT ablation (Procedure)
结局指标
主要结局
Time to first event comprising all-cause mortality, unplanned hospital admission for congestive heart failure and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)
时间窗: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.
次要结局
- Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy(From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.)
- Time to first unplanned cardiac hospitalization(From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.)
- Time to cardiac mortality(From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.)
- Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy(From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.)
- Time to first unplanned all-cause hospitalization(From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.)
- Changes in quality of life / mental(12 months)
- Changes in quality of life / physical(12 months)
- Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)(From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months..)
- Time to all-cause mortality(From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.)
研究者
研究点 (10)
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