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
Conditions:
🦠 Ventricular Tachycardia 🦠 Ischemic Cardiomyopathy
🗓️ Study Start (Actual) 12 April 2023
🗓️ Primary Completion (Estimated) 12 December 2027
✅ Study Completion (Estimated) 12 December 2028
👥 Enrollment (Estimated) 156
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    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:

    • * Serum creatinine \>1.5 mg/dL, or creatinine clearance \<30 ml/min
    • * 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
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 August 2022
  • First Submitted that Met QC Criteria 19 August 2022
  • First Posted 22 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 December 2023
  • Last Update Posted 3 January 2024
  • Last Verified December 2023