Venous Ethanol for Ventricular Tachycardia

• Status: Not yet recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute
• Treatments: Ethanol

Criteria

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