SERF Ablation for Ventricular Tachycardia

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thermedical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael Curley, PhD

Principal Investigator

Thermedical, Inc.

Eligibility Criteria

This trial is for adults with structural heart disease who have recurrent, drug-resistant ventricular tachycardia (VT) and an implantable cardioverter-defibrillator. Candidates must have experienced VT within the last 180 days and be able to consent. Excluded are those with severe heart failure, recent myocardial infarction or surgery, certain valve issues, life expectancy under a year, pregnancy, or conditions increasing risk of bleeding or thrombosis.

Inclusion Criteria

I am 18 years old or older.

Subject is able to provide informed consent

You have a heart device called an implantable cardioverter-defibrillator (ICD) with a history of documented occurrences of a heart rhythm problem called ventricular tachycardia (VT) within 6 months before the study.

See 2 more

Exclusion Criteria

My kidney function is low, with an eGFR under 30.

I have a condition that increases my risk of blood clots.

You are not allowed to have a cardiac CT scan.

See 24 more

Treatment Details

Interventions

Saline Enhanced Radiofrequency (SERF) Ablation (Radiofrequency Ablation)

Trial OverviewThe study tests Saline Enhanced Radiofrequency (SERF) Ablation using Thermedical's system on patients whose rapid heartbeat from VT doesn't respond to drugs or conventional ablation. It aims to see if SERF can safely and effectively stop these dangerous heart rhythms when other treatments fail.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Single arm treatmentExperimental Treatment1 Intervention

All subjects meeting inclusion/exclusion criteria and successfully consented will be treated with the study device.