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NCT Number: NCT05511246

Venous Ethanol for Ventricular Tachycardia

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous ethanol

Drug

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

Other names: Alcohol

Catheter ablation

Procedure

Endocardial catheter ablation of VT substrate

Primary outcomes

  1. Ventricular tachycardia recurrence

    Time frame: 0-12 months

    Detection of VT on defibrillator

  2. Hospitalization for cardiac causes

    Time frame: 0-12 months

  3. Severe procedural complications

    Time frame: 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.

  4. Death

    Time frame: 0-12 months

Secondary outcomes

  1. Procedural time

    Time frame: During procedure

    Total procedure time (minutes)

  2. Need for unplanned mechanical hemodynamic support

    Time frame: During procedure

    Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)

  3. Repeat ablation procedures, including epicardial

    Time frame: 0-12 months

    Need for repeat procedure (Yes/No)

  4. All-cause mortality

    Time frame: 0-12 months

  5. Appropriate ICD therapies: antitachycardia pacing and ICD shocks

    Time frame: 0-12 months

    Presence of appropriate ICD therapies on interrogation

  6. Inappropriate ICD therapies: antitachycardia pacing and ICD shocks

    Time frame: 0-12 months

    Presence of inappropriate ICD therapies on interrogation

  7. Change in ICD therapies compared to 3-months pre-randomization

    Time frame: 0-12 months

    Comparison of number of therapies on ICD interrogation

  8. Vt storm

    Time frame: 0-12 months

    More than 2 episodes of VT within a 24h period

  9. Sustained VT below detection rate

    Time frame: 0-12 months

  10. Change in left ventricular ejection fraction (percent)

    Time frame: Before and 3 months post-procedure

    Measured before and 3 months after procedure

  11. Quality of life measurement using SF-32 questionnaire

    Time frame: 0-12 months

    Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability

  12. Hospital admission for cardiac causes (including heart failure exacerbation)

    Time frame: 0-12 months

    Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)

  13. Antiarrhtyhmic therapy

    Time frame: 0-12 months

    Number of antiarrhythmic drugs before and after ablation

  14. Freedom from VT after repeat procedures

    Time frame: 0-12 months

    Recurrence of VT (yes/no) including patients that have multiple ablations

  15. Cardiac transplant or left ventricular assist device implantation

    Time frame: 0-12 months

    As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared

  16. Fluoroscopy time

    Time frame: During procedure

    Total time of fluoroscopy use (minutes)

  17. Total contrast agent used

    Time frame: During procedure

    Amount of radiographic contrast used (cc)

Study contacts

Contact information is provided by the study sponsor or research team.

Casey Kappenman

CONTACT

[email protected]

3462382367

Iris Melissa Alanis

CONTACT

[email protected]

7134416548

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Acronym: VELVET

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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