Venous Ethanol for Ventricular Tachycardia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Venous Ethanol for Ischemic Left Ventricular Tachycardia

Conditions
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Ventricular Tachycardia, Ischemic Cardiomyopathy

Intervention / Treatment
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* Drug: Venous ethanol
* Procedure: Catheter ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Endocardial radiofrequency ablation of ventricular tachycardia | Procedure: Catheter ablation<br>* Endocardial catheter ablation of VT substrate<br>|
| Experimental: Venous ethanol<br>Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate | Drug: Venous ethanol<br>* Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol<br>* Other names: Alcohol;Procedure: Catheter ablation<br>* Endocardial catheter ablation of VT substrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular tachycardia recurrence | Detection of VT on defibrillator | 0-12 months | 
| Hospitalization for cardiac causes |  | 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. | 0-12 months | 
| Death |  | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural time | Total procedure time (minutes) | During procedure | 
| Need for unplanned mechanical hemodynamic support | Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No) | During procedure | 
| Repeat ablation procedures, including epicardial | Need for repeat procedure (Yes/No) | 0-12 months | 
| All-cause mortality |  | 0-12 months | 
| Appropriate ICD therapies: antitachycardia pacing and ICD shocks | Presence of appropriate ICD therapies on interrogation | 0-12 months | 
| Inappropriate ICD therapies: antitachycardia pacing and ICD shocks | Presence of inappropriate ICD therapies on interrogation | 0-12 months | 
| Change in ICD therapies compared to 3-months pre-randomization | Comparison of number of therapies on ICD interrogation | 0-12 months | 
| Vt storm | More than 2 episodes of VT within a 24h period | 0-12 months | 
| Sustained VT below detection rate |  | 0-12 months | 
| Change in left ventricular ejection fraction (percent) | Measured before and 3 months after procedure | 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 | 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) | 0-12 months | 
| Antiarrhtyhmic therapy | Number of antiarrhythmic drugs before and after ablation | 0-12 months | 
| Freedom from VT after repeat procedures | Recurrence of VT (yes/no) including patients that have multiple ablations | 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 | 0-12 months | 
| Fluoroscopy time | Total time of fluoroscopy use (minutes) | During procedure | 
| Total contrast agent used | Amount of radiographic contrast used (cc) | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ethanol, Ventricular tachycardia, Coronary veins, Ablation