Venous Ethanol for Ventricular Tachycardia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Methodist Hospital Research Institute
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Venous ethanol
- Catheter ablation
Treatment groups
156 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov