SERF Ablation for Ventricular Tachycardia

Recruiting at 8 trial locations

Overseen By Michael Curley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thermedical, Inc.

Must be taking: Class III antiarrhythmics

Disqualifiers: Idiopathic VT, Atrial fibrillation, NYHA Class IV, Renal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

130 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants have recurrent ventricular tachycardia despite treatment with at least one Class III antiarrhythmic, suggesting that continuing some medications might be necessary. Please consult with the trial team for specific guidance.

What data supports the effectiveness of the treatment Saline Enhanced Radiofrequency (SERF) Ablation for Ventricular Tachycardia?

Research shows that Saline Enhanced Radiofrequency (SERF) Ablation can create deeper and more effective lesions in heart tissue, which is important for treating ventricular tachycardia (a type of fast heart rhythm). This method has been tested in humans and animals, showing promise in reaching the heart's deeper areas that are often hard to treat with standard methods. ^{1 2 3 4 5}

Is Saline Enhanced Radiofrequency (SERF) Ablation safe for humans?

Initial trials of Saline Enhanced Radiofrequency (SERF) Ablation for ventricular tachycardia in humans have been conducted to evaluate its safety and effectiveness. These studies are the first of their kind, indicating that the treatment is still in early stages of human testing, but they are designed to assess safety as a primary concern. ^{1 2 3 4 6}

How is the SERF Ablation treatment different from other treatments for ventricular tachycardia?

SERF Ablation is unique because it uses a needle-tip catheter to deliver heated saline along with radiofrequency energy directly into the heart tissue, creating deeper and more effective lesions to treat ventricular tachycardia. This approach allows for better penetration to reach the areas causing the abnormal heart rhythm, which is often a limitation with conventional ablation methods. ^{1 2 3 4 5}

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

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.

I have had a specific type of irregular heartbeat lasting more than 30 seconds in the past 6 months.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a study ablation procedure with the Thermedical Ablation System and Durablate catheter

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

4 visits (in-person) at 7 days, 30 days, 3 months, and 6 months

Treatment Details

Interventions

• Saline Enhanced Radiofrequency (SERF) Ablation

Trial Overview The 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

Group I: Single arm treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Thermedical, Inc.

Lead Sponsor

Trials

3

Recruited

170+

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of Saline-Enhanced Radiofrequency Needle-Tip Ablation for Ventricular Tachycardia (SERF VT CANADA Trial). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Characterization of Lesions Created by a Heated, Saline Irrigated Needle-Tip Catheter in the Normal and Infarcted Canine Heart. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Ablation of Refractory Ventricular Tachycardia Using Intramyocardial Needle Delivered Heated Saline-Enhanced Radiofrequency Energy: A First-in-Man Feasibility Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Characterization of warm saline-enhanced radiofrequency ablation lesions in the infarcted porcine ventricular myocardium. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Use of infrared thermography to delineate temperature gradients and critical isotherms during catheter ablation with normal and half normal saline: Implications for safety and efficacy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Saline-linked surface radiofrequency ablation: a safe and effective method of surface ablation of hepatic metastatic colorectal cancer. [2015]