Venous Ethanol for Ventricular Tachycardia

Официальное название

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Venous ethanol
  Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
• Процедура Catheter ablation
  Endocardial catheter ablation of VT substrate

Первичные конечные точки

• Ventricular tachycardia recurrence [Срок оценки: 0-12 months]
• Hospitalization for cardiac causes [Срок оценки: 0-12 months]
• Severe procedural complications [Срок оценки: 0-12 months]
• Death [Срок оценки: 0-12 months]

Вторичные конечные точки (12)

• Procedural time [Срок оценки: During procedure]
• Need for unplanned mechanical hemodynamic support [Срок оценки: During procedure]
• Repeat ablation procedures, including epicardial [Срок оценки: 0-12 months]
• All-cause mortality [Срок оценки: 0-12 months]
• Appropriate ICD therapies: antitachycardia pacing and ICD shocks [Срок оценки: 0-12 months]
• Inappropriate ICD therapies: antitachycardia pacing and ICD shocks [Срок оценки: 0-12 months]
• Change in ICD therapies compared to 3-months pre-randomization [Срок оценки: 0-12 months]
• Vt storm [Срок оценки: 0-12 months]
• Sustained VT below detection rate [Срок оценки: 0-12 months]
• Change in left ventricular ejection fraction (percent) [Срок оценки: Before and 3 months post-procedure]
• Quality of life measurement using SF-32 questionnaire [Срок оценки: 0-12 months]
• Hospital admission for cardiac causes (including heart failure exacerbation) [Срок оценки: 0-12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Houston Methodist Hospital — Houston

Идентификаторы

NCT: NCT05511246 · ADM00021434

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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