Venous Ethanol for Ventricular Tachycardia

NCT05511246 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ADM00021434
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Keywords

Ventricular tachycardia; Coronary veins; Ethanol; Ablation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

• Procedural time

  During procedure

• Need for unplanned mechanical hemodynamic support

  During procedure

• Repeat ablation procedures, including epicardial

  0-12 months

• All-cause mortality

  0-12 months

• Appropriate ICD therapies: antitachycardia pacing and ICD shocks

  0-12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Endocardial radiofrequency ablation of ventricular tachycardia

Procedure: Catheter ablation

Venous ethanol

EXPERIMENTAL

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

Drug: Venous ethanol; Procedure: Catheter ablation

Interventions

Venous ethanol DRUG

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

Also known as: Alcohol

Venous ethanol

Catheter ablation PROCEDURE

Endocardial catheter ablation of VT substrate

Control; Venous ethanol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Ethanol; Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Miguel Valderrabano, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Melissa Alanis

CONTACT

7134416548; imalanis@houstonmethodist.org

Casey Kappenman

CONTACT

3462382367; cjkappenman@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 22, 2022
• Study Start: April 12, 2023
• Primary Completion (Estimated): December 12, 2027
• Study Completion (Estimated): December 12, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)