Venous Ethanol for Ventricular Tachycardia (VELVET)

Venous Ethanol for Ischemic Left 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

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy
• Intervention / Treatment: Procedure: Catheter ablation; Drug: Venous ethanol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Casey Kappenman; Phone Number: 3462382367; Email: cjkappenman@houstonmethodist.org
• Study Contact Backup: Name: Iris Melissa Alanis; Phone Number: 7134416548; Email: imalanis@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Principal Investigator: Miguel Valderrabano, MD
      • Contact: Chinwe Ngumezi, RN; Phone Number: 346-238-0290; Email: ccngumezi@houstonmethodist.org
      • Contact: Iris Melissa Alanis; Phone Number: 7134416548; Email: imalanis@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Endocardial radiofrequency ablation of ventricular tachycardia	Procedure: Catheter ablation; Endocardial catheter ablation of VT substrate
Experimental: Venous ethanol; Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate	Procedure: Catheter ablation; Endocardial catheter ablation of VT substrate; Drug: Venous ethanol; Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol; Other Names: Alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular tachycardia recurrence	Detection of VT on defibrillator	0-12 months
Hospitalization for cardiac causes		0-12 months
Severe procedural complications	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.	0-12 months
Death		0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time	Total procedure time (minutes)	During procedure
Need for unplanned mechanical hemodynamic support	Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)	During procedure
Repeat ablation procedures, including epicardial	Need for repeat procedure (Yes/No)	0-12 months
All-cause mortality		0-12 months
Appropriate ICD therapies: antitachycardia pacing and ICD shocks	Presence of appropriate ICD therapies on interrogation	0-12 months
Inappropriate ICD therapies: antitachycardia pacing and ICD shocks	Presence of inappropriate ICD therapies on interrogation	0-12 months
Change in ICD therapies compared to 3-months pre-randomization	Comparison of number of therapies on ICD interrogation	0-12 months
Vt storm	More than 2 episodes of VT within a 24h period	0-12 months
Sustained VT below detection rate		0-12 months
Change in left ventricular ejection fraction (percent)	Measured before and 3 months after procedure	Before and 3 months post-procedure
Quality of life measurement using SF-32 questionnaire	Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability	0-12 months
Hospital admission for cardiac causes (including heart failure exacerbation)	Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)	0-12 months
Antiarrhtyhmic therapy	Number of antiarrhythmic drugs before and after ablation	0-12 months
Freedom from VT after repeat procedures	Recurrence of VT (yes/no) including patients that have multiple ablations	0-12 months
Cardiac transplant or left ventricular assist device implantation	As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared	0-12 months
Fluoroscopy time	Total time of fluoroscopy use (minutes)	During procedure
Total contrast agent used	Amount of radiographic contrast used (cc)	During procedure

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Miguel Valderrabano, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): December 12, 2027
• Study Completion (Estimated): December 12, 2028

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ethanol; Ablation; Ventricular tachycardia; Coronary veins
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Organic Chemicals; Therapeutics; Surgical Procedures, Operative; Alcohols; Ablation Techniques; Radiofrequency Ablation; Radiofrequency Therapy; Ethanol; Catheter Ablation
• Other Study ID Numbers: ADM00021434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No