Venous Ethanol for Ventricular Tachycardia

Phase 2

Recruiting

• Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy
• Interventions: Procedure: Catheter ablation; Drug: Venous ethanol

• Registration Number: NCT05511246
• Lead Sponsor: The Methodist Hospital Research Institute

Brief 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

Detailed Description

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 Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2023-04-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-03
• Primary Completion: 2027-12-12
• Study Completion: 2028-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Catheter ablation	Endocardial radiofrequency ablation of ventricular tachycardia
Venous ethanol	Catheter ablation	Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate
Venous ethanol	Venous ethanol	Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate

Primary Outcome Measures

Name	Time	Method
Death	0-12 months
Severe procedural complications	0-12 months	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.
Ventricular tachycardia recurrence	0-12 months	Detection of VT on defibrillator
Hospitalization for cardiac causes	0-12 months

Secondary Outcome Measures

Name	Time	Method
Procedural time	During procedure	Total procedure time (minutes)
Repeat ablation procedures, including epicardial	0-12 months	Need for repeat procedure (Yes/No)
Inappropriate ICD therapies: antitachycardia pacing and ICD shocks	0-12 months	Presence of inappropriate ICD therapies on interrogation
Change in ICD therapies compared to 3-months pre-randomization	0-12 months	Comparison of number of therapies on ICD interrogation
Vt storm	0-12 months	More than 2 episodes of VT within a 24h period
Hospital admission for cardiac causes (including heart failure exacerbation)	0-12 months	Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)
Antiarrhtyhmic therapy	0-12 months	Number of antiarrhythmic drugs before and after ablation
Appropriate ICD therapies: antitachycardia pacing and ICD shocks	0-12 months	Presence of appropriate ICD therapies on interrogation
Change in left ventricular ejection fraction (percent)	Before and 3 months post-procedure	Measured before and 3 months after procedure
Quality of life measurement using SF-32 questionnaire	0-12 months	Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability
All-cause mortality	0-12 months
Sustained VT below detection rate	0-12 months
Need for unplanned mechanical hemodynamic support	During procedure	Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)
Total contrast agent used	During procedure	Amount of radiographic contrast used (cc)
Freedom from VT after repeat procedures	0-12 months	Recurrence of VT (yes/no) including patients that have multiple ablations
Cardiac transplant or left ventricular assist device implantation	0-12 months	As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared
Fluoroscopy time	During procedure	Total time of fluoroscopy use (minutes)

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States