NCT05511246

Venous Ethanol for Ventricular Tachycardia

Venous Ethanol for Ischemic Left Ventricular Tachycardia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardia
• Ischemic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Venous ethanol	Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
PROCEDURE	Catheter ablation	Endocardial catheter ablation of VT substrate

Timeline

• Start date: 2023-04-12
• Primary completion: 2027-12-12
• Completion: 2028-12-12
• First posted: 2022-08-22
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study