# VENOUS ETHANOL ABLATION IN ISCHEMIC VENTRICULAR TACHYCARDIA- VELVET TRIAL

> **NIH NIH R33** · METHODIST HOSPITAL RESEARCH INSTITUTE · 2024 · $691,087

## Abstract

Abstract
Radiofrequency (RF) ablation of ventricular tachycardia (VT) in ischemic cardiomyopathy is fraught with
limitations due to suboptimal efficacy, risk of complications, and frequent need for repeat procedures. Ischemic
VT arises as a result of reentrant circuits within or around the myocardial scar of an infarct. The co-localization
of ventricular arteries, veins, and nerves, is an anatomical fact, determined by the embryology of coronary
vessels. Just as myocardial infarctions have a “culprit” or “infarct-related artery”, there commonly exists an
“infarct-related vein” or veins in VT substrate. Additionally, it is well known that autonomic innervation -in
anatomical proximity to the veins- plays an important role in post-MI arrhythmogenesis. We have developed an
approach to target ablation-refractory VTs via ethanol delivery in the coronary veins that provide venous return
from arrhythmogenic sites (venous ethanol, VE). Beyond an initial set of case reports, we have validated the
utility of VE in a large, multinational registry, in which we establish the safety and efficacy of VE in RF-refractory
VT. Given the co-localization of epicardial arteries, veins and nerves, VE may be particularly suited to impact
infarct innervation. Thus, a central goal of this proposal is to capitalize on the presence of coronary veins on the
epicardial aspect of a myocardial scar as a therapeutic opportunity of unique mechanisms. We hypothesize that
VE added to conventional catheter ablation improves the results of VT ablation. We propose a single-site,
investigator-initiated clinical trial on VE.
In Aim 1-R61 phase-, we propose to finalize the design of randomized clinical trial to assess the clinical efficacy,
and safety of VE when used in combination with RF ablation compared with RF ablation alone -Venous Ethanol
for Left Ventricular Ischemic VEntricular Tachycardia -VELVET clinical trial. The trial will include an
investigational new drug (IND) authorization by the FDA. Patients with ischemic VT will be randomized to
conventional endocardial ablation alone, vs combined with VE in the infarct-related vein.
In Aim 2 -R33 phase- we will enroll a total of 156 patients, and collect efficacy, safety and procedural data on
the impact of VE added to catheter ablation. This trial will allow for a wealth of new imaging data to be collected
that will characterize the extent of myocardial scar and innervation before and after VE -compared to endocardial
RF alone. In Aim 3 -R33 phase- we will collect multi-modality imaging data characterizing the VT substrate before
and after ablation -with catheter ablation alone vs combined with VE. Cardiac magnetic resonance, venous CT
angiograms and regional adrenergic innervation maps with positron emission tomography (PET) scans of
innervation tracers (11C hydroxyephedrine, 11C-HED) will provide a complete structural assessment of the VT
substrate, before and after ablation.
If completed, the project will validate a new procedu...

## Key facts

- **NIH application ID:** 11064972
- **Project number:** 4R33HL164873-02
- **Recipient organization:** METHODIST HOSPITAL RESEARCH INSTITUTE
- **Principal Investigator:** Miguel Valderrabano
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $691,087
- **Award type:** 4N
- **Project period:** 2024-09-01 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11064972

## Citation

> US National Institutes of Health, RePORTER application 11064972, VENOUS ETHANOL ABLATION IN ISCHEMIC VENTRICULAR TACHYCARDIA- VELVET TRIAL (4R33HL164873-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11064972. Licensed CC0.

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