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
Patients with ventricular tachycardia (VT) in the context of ischemic heart disease suffer from significant morbidity and mortality. Catheter ablation can improve outcomes but has suboptimal ablation results. Ethanol ablation via epicardial veins can add significant therapeutic value to catheter ablation by increasing reach to intramural VT substrates. Investigators will randomize patients with ischemic VT to either endocardial catheter ablation alone, or combined with venous ethanol (VE) ablation of coronary veins located on the epicardial aspect of the VT substrates. A combined primary endpoint: VT recurrence, procedural complications, hospitalization for cardiac causes, and death, will be measured over a 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
Endocardial catheter ablation of VT substrate
Houston Methodist Hospital
Houston, Texas, United States
RECRUITINGVentricular tachycardia recurrence
Detection of VT on defibrillator
Time frame: 0-12 months
Hospitalization for cardiac causes
Time frame: 0-12 months
Severe procedural complications
Severe procedural complications include bleeding requiring transfusion, stroke or systemic embolization, pericardial tamponade, myocardial infarction, and vascular complications requiring surgery, plus cardiogenic shock requiring unplanned mechanical support.
Time frame: 0-12 months
Death
Time frame: 0-12 months
Procedural time
Total procedure time (minutes)
Time frame: During procedure
Need for unplanned mechanical hemodynamic support
Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)
Time frame: During procedure
Repeat ablation procedures, including epicardial
Need for repeat procedure (Yes/No)
Time frame: 0-12 months
All-cause mortality
Time frame: 0-12 months
Appropriate ICD therapies: antitachycardia pacing and ICD shocks
Presence of appropriate ICD therapies on interrogation
Time frame: 0-12 months
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Inappropriate ICD therapies: antitachycardia pacing and ICD shocks
Presence of inappropriate ICD therapies on interrogation
Time frame: 0-12 months
Change in ICD therapies compared to 3-months pre-randomization
Comparison of number of therapies on ICD interrogation
Time frame: 0-12 months
Vt storm
More than 2 episodes of VT within a 24h period
Time frame: 0-12 months
Sustained VT below detection rate
Time frame: 0-12 months
Change in left ventricular ejection fraction (percent)
Measured before and 3 months after procedure
Time frame: Before and 3 months post-procedure
Quality of life measurement using SF-32 questionnaire
Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability
Time frame: 0-12 months
Hospital admission for cardiac causes (including heart failure exacerbation)
Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)
Time frame: 0-12 months
Antiarrhtyhmic therapy
Number of antiarrhythmic drugs before and after ablation
Time frame: 0-12 months
Freedom from VT after repeat procedures
Recurrence of VT (yes/no) including patients that have multiple ablations
Time frame: 0-12 months
Cardiac transplant or left ventricular assist device implantation
As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared
Time frame: 0-12 months
Fluoroscopy time
Total time of fluoroscopy use (minutes)
Time frame: During procedure
Total contrast agent used
Amount of radiographic contrast used (cc)
Time frame: During procedure