Recruiting
Phase 2

Venous Ethanol

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT05511246

Conditions

Ventricular Tachycardia

Ischemic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Venous ethanol

Catheter ablation

Study Details

Brief summary:

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

Conditions

Ventricular Tachycardia

Ischemic Cardiomyopathy

Study ID

NCT05511246

Start date

Apr 12, 2023

Status verified date

Jul, 2026

Completion date

Dec 12, 2028

Anticipated

Primary completion date

Dec 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

Endocardial radiofrequency ablation of ventricular tachycardia

experimental: Venous ethanol

Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate

Interventions

Venous ethanol

Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol

Catheter ablation

Endocardial catheter ablation of VT substrate

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Iris Melissa Alanis

7134416548imalanis@houstonmethodist.org

Casey Kappenman

3462382367cjkappenman@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Chinwe Ngumezi, RN

346-238-0290ccngumezi@houstonmethodist.org

Iris Melissa Alanis

7134416548imalanis@houstonmethodist.org

Principal Investigator:

Miguel Valderrabano, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Ventricular tachycardia
  • Coronary veins
  • Ethanol
  • Ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-07-24.