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Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

NCT05337241 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-08-14

No results posted yet for this study

Summary

The Thermedical Ablation System and Durablate catheter is indicated for use in patients with recurrent, sustained, monomorphic ventricular tachycardia (SMVT) refractory to drug therapy and conventional (approved) catheter ablation.

Subjects with recurrent, SMVT refractory to drug therapy and conventional catheter ablation who are not eligible for, or will not likely benefit from repeat endocardial ablation using an approved catheter.

Conditions

  • Refractory Ventricular Tachycardia

Interventions

DEVICE

Saline Enhanced Radiofrequency (SERF) Ablation

The Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates

Sponsors & Collaborators

  • Thermedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Curley, PhD · Thermedical, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-09
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05337241 on ClinicalTrials.gov