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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
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old and have had an ICD implanted.
Select...
I have heart muscle damage from a past heart attack.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Severe procedural complications
Ventricular tachycardia recurrence
Secondary study objectives
Therapeutic procedure
Appropriate ICD therapies: antitachycardia pacing and ICD shocks
Cardiac transplant or left ventricular assist device implantation
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1260
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
287 Previous Clinical Trials
81,624 Total Patients Enrolled
Miguel Valderrabano, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
1 Previous Clinical Trials
423 Total Patients Enrolled