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RECRUITINGPhase 2INTERVENTIONAL

Venous Ethanol for Ventricular Tachycardia

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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: * 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

Treatments Being Tested

DRUG

Venous ethanol

Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol

PROCEDURE

Catheter ablation

Endocardial catheter ablation of VT substrate

Locations (1)

Houston Methodist Hospital
Houston, Texas, United States