Venous Ethanol for Ventricular Tachycardia (VELVET) Clinical Trial

This study is looking at new ways to treat Ventricular Tachycardia (VT), a fast and irregular heartbeat, in people with Ischemic Cardiomyopathy (heart muscle damage from blocked arteries). It compares two treatments: Catheter Ablation (a procedure using heat to destroy faulty heart tissue) alone, versus Catheter Ablation combined with Venous Ethanol. Venous Ethanol involves injecting ethanol into veins near the heart to help stop VT. You might be able to join if you are 18-85 years old, have an implanted defibrillator (ICD), have Ischemic Cardiomyopathy, and have experienced VT episodes in the last six months. The study will measure if these treatments reduce VT recurrence, hospitalizations for heart problems, and severe complications over 12 months. The current status of this study is unclear.

Study design
This is a comparative effectiveness randomized clinical trial, meaning participants will be randomly assigned to one of two treatment groups. The study aims to enroll 156 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment to check for VT recurrence, hospitalizations, and complications.

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NCT05511246

Venous Ethanol for Ventricular Tachycardia

Recruiting
PHASE2Ages 18–85InterventionalTreatment
The Methodist Hospital Research Institute
~156 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Venous ethanolCatheter ablation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ventricular tachycardia recurrence
Measured over 0-12 months
+3 more outcomes measured
Ventricular Tachycardia
Ischemic Cardiomyopathy
1 sites across 1 states
Texas1
  • Miguel Valderrabano, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Ventricular tachycardia recurrence0-12 months

    Detection of VT on defibrillator

  • Hospitalization for cardiac causes0-12 months
  • Severe procedural complications0-12 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.

  • Death0-12 months