Venous Ethanol for Ventricular Tachycardia (VELVET)

March 25, 2026 updated by: The Methodist Hospital Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ventricular tachycardia recurrence
Time Frame: 0-12 months
Detection of VT on defibrillator
0-12 months
Hospitalization for cardiac causes
Time Frame: 0-12 months
0-12 months
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.
0-12 months
Death
Time Frame: 0-12 months
0-12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural time
Time Frame: During procedure
Total procedure time (minutes)
During procedure
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)
During procedure
Repeat ablation procedures, including epicardial
Time Frame: 0-12 months
Need for repeat procedure (Yes/No)
0-12 months
All-cause mortality
Time Frame: 0-12 months
0-12 months
Appropriate ICD therapies: antitachycardia pacing and ICD shocks
Time Frame: 0-12 months
Presence of appropriate ICD therapies on interrogation
0-12 months
Inappropriate ICD therapies: antitachycardia pacing and ICD shocks
Time Frame: 0-12 months
Presence of inappropriate ICD therapies on interrogation
0-12 months
Change in ICD therapies compared to 3-months pre-randomization
Time Frame: 0-12 months
Comparison of number of therapies on ICD interrogation
0-12 months
Vt storm
Time Frame: 0-12 months
More than 2 episodes of VT within a 24h period
0-12 months
Sustained VT below detection rate
Time Frame: 0-12 months
0-12 months
Change in left ventricular ejection fraction (percent)
Time Frame: Before and 3 months post-procedure
Measured before and 3 months after procedure
Before and 3 months post-procedure
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
0-12 months
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)
0-12 months
Antiarrhtyhmic therapy
Time Frame: 0-12 months
Number of antiarrhythmic drugs before and after ablation
0-12 months
Freedom from VT after repeat procedures
Time Frame: 0-12 months
Recurrence of VT (yes/no) including patients that have multiple ablations
0-12 months
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
0-12 months
Fluoroscopy time
Time Frame: During procedure
Total time of fluoroscopy use (minutes)
During procedure
Total contrast agent used
Time Frame: During procedure
Amount of radiographic contrast used (cc)
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Methodist Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Miguel Valderrabano, MD, The Methodist Hospital Research Institute

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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