Venous Ethanol for Ischemic Left Ventricular Tachycardia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial
详细描述
Patients with ventricular tachycardia (VT) in the context of ischemic heart disease suffer from significant morbidity and mortality. Catheter ablation can improve outcomes but has suboptimal ablation results. Ethanol ablation via epicardial veins can add significant therapeutic value to catheter ablation by increasing reach to intramural VT substrates. Investigators will randomize patients with ischemic VT to either endocardial catheter ablation alone, or combined with venous ethanol (VE) ablation of coronary veins located on the epicardial aspect of the VT substrates. A combined primary endpoint: VT recurrence, procedural complications, hospitalization for cardiac causes, and death, will be measured over a 12-month follow-up.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, ages of 18 and 85 years and with a prior ICD implant
- •Diagnosed with ischemic cardiomyopathy: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)
- •One of the following VT events (within last 6 months): a) ≥3 episodes of VT treated with anti-tachycardia pacing (ATP) or anti-arrhythmic drugs; b) ≥1 appropriate ICD shocks; c) ≥3 VT episodes within 24 hr; d) sustained VT below detection rate of the ICD documented by EKG/cardiac monitor
- •Patients deemed candidates for RF ablation of VT
- •Able and willing to comply with pre-, post-, and follow-up requirements
- •Willing to sign the informed consent
排除标准
- •Creatinine clearance <25 cc/min (using Cockcroft-Gault equation) except for patients on dialysis. (Contrast induced nephropathy is irrelevant in end-stage renal disease patients on dialysis, in whom the concern for contrast-induced renal dysfunction is not there since there is no chance of further kidney damage). Additionally, patients on dialysis will be excluded from the imaging sub-study.
- •Left ventricular (LV) ejection fraction ≤10%
- •Mobile LV thrombus on echocardiography
- •Absence of vascular access to the LV
- •Disease process likely to limit survival to <12 months
- •New York Heart Association class IV heart failure
- •Cardiac surgery within the past 2 months (unless VT was incessant),
- •Acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on EKG)
- •Another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)
- •Severe aortic stenosis or mitral regurgitation with a flail leaflet
- •Pregnancy
- •Unwilling or unable to provide informed consent
- •Covid-19 positive testing within 14 days of randomization procedure
- •Enrolled, or planning to get enrolled, in another research study during his/her participation on the Velvet trial
研究组 & 干预措施
Control
Endocardial radiofrequency ablation of ventricular tachycardia
干预措施: Catheter ablation (Procedure)
Venous ethanol
Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate
干预措施: Venous ethanol (Drug)
Venous ethanol
Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate
干预措施: Catheter ablation (Procedure)
结局指标
主要结局
Death
时间窗: 0-12 months
Severe procedural complications
时间窗: 0-12 months
Severe procedural complications include bleeding requiring transfusion, stroke or systemic embolization, pericardial tamponade, myocardial infarction, and vascular complications requiring surgery, plus cardiogenic shock requiring unplanned mechanical support.
Ventricular tachycardia recurrence
时间窗: 0-12 months
Detection of VT on defibrillator
Hospitalization for cardiac causes
时间窗: 0-12 months
次要结局
- Procedural time(During procedure)
- Repeat ablation procedures, including epicardial(0-12 months)
- Inappropriate ICD therapies: antitachycardia pacing and ICD shocks(0-12 months)
- Change in ICD therapies compared to 3-months pre-randomization(0-12 months)
- Vt storm(0-12 months)
- Hospital admission for cardiac causes (including heart failure exacerbation)(0-12 months)
- Antiarrhtyhmic therapy(0-12 months)
- All-cause mortality(0-12 months)
- Sustained VT below detection rate(0-12 months)
- Need for unplanned mechanical hemodynamic support(During procedure)
- Appropriate ICD therapies: antitachycardia pacing and ICD shocks(0-12 months)
- Change in left ventricular ejection fraction (percent)(Before and 3 months post-procedure)
- Quality of life measurement using SF-32 questionnaire(0-12 months)
- Total contrast agent used(During procedure)
- Freedom from VT after repeat procedures(0-12 months)
- Cardiac transplant or left ventricular assist device implantation(0-12 months)
- Fluoroscopy time(During procedure)