Alcohol injection plus standard procedure may calm deadly heart rhythm
NCT ID NCT05511246
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests whether adding a vein-injected alcohol treatment to the usual heart ablation procedure can better control dangerous heart rhythms in people with prior heart attacks. About 156 adults with an implanted defibrillator and recent episodes of rapid heartbeat will be randomly assigned to standard ablation alone or ablation plus the alcohol injection. The goal is to see if the combination reduces repeat episodes, hospital stays, and serious complications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Hospital
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Mapping the Heart's hidden short circuits: a new ablation strategy for dangerous rhythms
- Can a new electric pulse technique tame Post-Heart-Attack heart rhythms faster?
- A blood test that foresees heart rhythms?
- Can a higher dose of heart radiation stop dangerous rhythms?
- Can two advanced heart maps guide a more precise fix for dangerous arrhythmias?
- Could a short course of steroids calm a dangerous heart rhythm?