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Venous ethanol for Ventricular Tachycardia (VELVET Trial)

Phase 2

Recruiting

Led By Miguel Valderrabano, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-12 months

Awards & highlights

VELVET Trial Summary

This trial is comparing two treatments for a heart condition called ischemic ventricular tachycardia. One treatment involves using radiofrequency ablation alone, while the other treatment combines radiofrequency ablation

Who is the study for?

This trial is for men and women aged 18-85 with ischemic cardiomyopathy, evidenced by a past heart attack or heart muscle issues. They must have had multiple rapid heartbeat episodes treated with pacing or drugs, an ICD shock, or documented ventricular tachycardia. Candidates should be eligible for radiofrequency ablation therapy and willing to follow the study's procedures.Check my eligibility

What is being tested?

The VELVET clinical trial is testing two treatments for severe rapid heartbeat due to heart muscle damage: one group receives standard catheter ablation while the other gets additional venous ethanol treatment. Participants are randomly assigned to either method.See study design

What are the potential side effects?

Potential side effects may include discomfort at the catheter insertion site, bleeding, infection risk from the procedure, possible damage to blood vessels or heart tissue from ablation or ethanol injection, arrhythmias (irregular heartbeats), and rarely more serious complications.

VELVET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old and have had an ICD implanted.

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I have heart muscle damage from a past heart attack.

VELVET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Death

Hospitalization for cardiac causes

Severe procedural complications

+1 more

Secondary outcome measures

All-cause mortality

Therapeutic procedure

Appropriate ICD therapies: antitachycardia pacing and ICD shocks

+14 more

VELVET Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Venous ethanolExperimental Treatment2 Interventions

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

Group II: ControlActive Control1 Intervention

Endocardial radiofrequency ablation of ventricular tachycardia

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Catheter ablation

2016

Completed Phase 4

~810

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,379 Total Patients Enrolled

Miguel Valderrabano, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

1 Previous Clinical Trials

423 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently accepting new participants?

"According to the information available on clinicaltrials.gov, this study is presently enrolling participants. The trial was initially posted on April 12th, 2023 and underwent its most recent update on December 28th, 2023."

Answered by AI

What is the overall count of individuals involved in this clinical research?

"Indeed, the information found on clinicaltrials.gov indicates that this specific study is actively seeking eligible candidates. The trial was initially posted on April 12th, 2023 and received its most recent update on December 28th, 2023. A total of 156 patients will be enrolled in this study across a single designated site."

Answered by AI

Is the inclusion criteria for this trial limited to individuals who have reached adulthood, specifically 18 years or older?

"To be eligible for this clinical trial, participants must fall within the age range of 18 to 85. It's worth noting that there are currently 27 studies available for individuals under the age of 18 and an additional 253 studies catering specifically to patients over the age of 65."

Answered by AI

What are the risks associated with administering ethyl alcohol through veins for patients?

"Given that this trial is in Phase 2, there is limited safety data available for venous ethanol. Therefore, our team at Power rates the safety of venous ethanol as a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venous Ethanol for Ventricular Tachycardia

2023. "Venous Ethanol for Ventricular Tachycardia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05511246.

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