Venous Ethanol for Ventricular Tachycardia (VELVET)

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Enrolling; Phase 2

Conditions: Ischemic Cardiomyopathy; Ventricular Tachycardia

Treatments: Drug: Venous ethanol; Procedure: Catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05511246

ADM00021434

Details and patient eligibility

About

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

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 2 patient groups

Control

Active Comparator group

Description:

Endocardial radiofrequency ablation of ventricular tachycardia

Treatment:

Procedure: Catheter ablation

Venous ethanol

Experimental group

Description:

Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate

Treatment:

Procedure: Catheter ablation

Drug: Venous ethanol