# Eliminating Ventricular Tachycardia: Pivotal Clinical Trial using the Durablate® Catheter

> **NIH NIH R44** · THERMEDICAL, INC. · 2024 · $1,210,431

## Abstract

Ventricular tachycardia (VT) causes more than half of the 170,000–450,000 sudden cardiac
deaths (SCD) that occur annually in the United States. Implantable cardioverter defibrillators
(ICDs) are the standard of care, but they are expensive (the total cost of an ICD implant
exceeds $50,000) and not curative. Patients who receive ICDs are subject to shocks to halt
episodes of VT, and those shocks can be painful and traumatic. RF ablation represents a
potential method for curing VT, at a much lower cost than ICDs, but while RF ablation has been
successful at treating atrial arrhythmias, it is not as effective at treating VT. An ablation tool
capable of treating VT has the potential to improve ICD therapy by eliminating shocks or even
the need for ICD implants, greatly reducing the cost to the health care system of treating VT
while also improving the lives of patients affected by VT. Recent advances in 3-D
reconstruction of CT or MRI images and with merging those images with electroanatomic maps
have made identification of the tissue that needs to be ablated easier. We have developed the
ablation tool that can reliably treat all VT foci.
We have developed the Durablate® Catheter and SERF ablation specifically the treatment of
VT. Our technology delivers heated saline along with RF energy and is unique in its ability to
treat the large volumes of cardiac tissue necessary to eliminate arrhythmogenic tissue located
either on the endocardial surface or deep in the ventricular wall. Our technology can treat much
larger volumes of tissue than conventional RF because saline carries the heat generated by RF
into tissue by convection. We also have fine control over the size of the ablated lesion since we
have control over the amount of saline delivered. SERF lesions can be as small or as large as
the physician needs and they will be the size the physician calls for.
We have successfully concluded a small first-in-human study whose results were recently
published in Circulation: Arrhythmia and Electrophysiology. An accompanying editorial
described the results as “impressive” in a patient population with “clinical characteristics that
would intimidate even the most optimistic and experienced VT ablation enthusiasts.” The FDA
has awarded our technology Breakthrough Device Designation and has approved our IDE for
our pivotal clinical trial.
We will conduct the 154-patient single-arm study at seven centers. Patients will be eligible for
the study if they have recurrent, symptomatic VT; if they have failed prior cardiac catheter VT
ablation; if the etiology of the arrhythmia is related to structural heart disease; or if a target
arrhythmia has been treated by an implanted ICD. Successful completion of this clinical trial will
result in the US clearance for the Durablate catheter and will offer an underserved patient
population a better quality of life and the possibility of a cure.

## Key facts

- **NIH application ID:** 10928202
- **Project number:** 5R44HL169112-02
- **Recipient organization:** THERMEDICAL, INC.
- **Principal Investigator:** MICHAEL G CURLEY
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,210,431
- **Award type:** 5
- **Project period:** 2023-09-12 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10928202

## Citation

> US National Institutes of Health, RePORTER application 10928202, Eliminating Ventricular Tachycardia: Pivotal Clinical Trial using the Durablate® Catheter (5R44HL169112-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10928202. Licensed CC0.

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