Venous Ethanol for Ventricular Tachycardia

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Aug 19, 2022

Keywords

ClinConnect Summary

The VELVET clinical trial is studying a new treatment approach for patients with a heart condition called ischemic ventricular tachycardia, which can cause a fast and irregular heartbeat. Researchers want to see if combining a standard procedure called radiofrequency ablation with a substance called venous ethanol is more effective than using radiofrequency ablation alone. This trial is currently recruiting participants aged 18 to 85 who have already had a device implanted to help manage their heart rhythm and have experienced certain heart-related events in the past six months.

Eligible participants can expect to undergo the assigned treatment and will be closely monitored both before and after the procedure. They will need to commit to follow-up appointments and be willing to sign consent forms to participate. It's important to note that certain health conditions or recent surgeries may prevent someone from joining the trial, so potential participants should discuss their specific circumstances with their doctors. This study aims to find better options for managing this serious heart condition and improve patient outcomes.

Gender

ALL

Eligibility 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