Venous Ethanol for Ventricular Tachycardia
Venous Ethanol for Ischemic Left Ventricular Tachycardia
The Methodist Hospital Research Institute
156 participants
Apr 12, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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 Criteria14
- 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
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Interventions
Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
Endocardial catheter ablation of VT substrate
Locations(1)
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NCT05511246