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RECRUITING
NCT05337241
NA

Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Sponsor: Thermedical, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-08-09

Completion Date

2027-06-30

Last Updated

2025-08-14

Healthy Volunteers

No

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

Locations (7)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Intermountain Healthcare

Salt Lake City, Utah, United States

Montreal Heart Institute - Institut de Cardiologie de Montréal

Montreal, Quebec, Canada

Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada