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New treatment option for Ventricular Tachycardia
Official title Venous Ethanol for Ventricular Tachycardia
ClinicalTrials.gov ID: NCT05511246
What this study is testing
What is Venous ethanol?
Venous ethanol is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for ventricular tachycardia.
Also referred to as Alcohol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- 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)...
- Patients deemed candidates for RF ablation of VT
- Able and willing to comply with pre-, post-, and follow-up requirements
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.