Venous Ethanol for Ventricular Tachycardia (NCT05511246) | Clinical Trial Compass
RecruitingPhase 2
Venous Ethanol for Ventricular Tachycardia
United States156 participantsStarted 2023-04-12
Plain-language 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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Creatinine clearance \<25 cc/min (using Cockcroft-Gault equation) except for patients on dialysis. (Contrast induced nephropathy is irrelevant in end-stage renal disease patients on dialysis, in whom the concern for contrast-induced renal dysfunction is not there since there is no chance of further kidney damage). Additionally, patients on dialysis will be excluded from the imaging sub-study.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.