SERF Ablation for Ventricular Tachycardia

Recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called Saline Enhanced Radiofrequency (SERF) Ablation for individuals with a persistent heart rhythm problem known as monomorphic ventricular tachycardia (SMVT). It focuses on those whose condition hasn't improved with medication or standard procedures. The trial welcomes participants who have experienced multiple episodes of this condition despite previous treatments and have an implantable cardioverter-defibrillator, a device that helps regulate heart rhythms. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that the Thermedical Ablation System and Durablate catheter is safe for treating ventricular tachycardia?

Research has shown that Saline Enhanced Radiofrequency (SERF) Ablation is generally well-tolerated. In one study, 42 out of 43 cases of fast heart rhythms were successfully treated, indicating the procedure's effectiveness for nearly all participants. Another study found that more than half of the patients did not experience a recurrence of their heart rhythm problem after five months.

While the treatment appears promising, patients with certain heart conditions require special care to avoid complications. The studies reported no major side effects, suggesting the treatment is safe for most people. It is crucial to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Saline Enhanced Radiofrequency (SERF) Ablation is unique because it introduces a new technique to treating ventricular tachycardia, a dangerous heart rhythm disorder. Unlike traditional ablation methods that use standard radiofrequency energy, SERF Ablation enhances this process with saline, which may improve the precision and effectiveness of the treatment. Researchers are excited because this method could potentially target the heart tissue more accurately, reducing the risk of damaging surrounding healthy tissue and improving outcomes for patients.

What evidence suggests that the Thermedical Ablation System and Durablate catheter is effective for ventricular tachycardia?

Research has shown that Saline Enhanced Radiofrequency (SERF) Ablation is a promising treatment for ventricular tachycardia (VT), particularly when other treatments fail. In one study, SERF ablation successfully stopped 98% of abnormal heart rhythms. Another study found that after five months, more than half of the patients experienced no VT episodes, and over 60% reported feeling better. This technique uses heated saltwater to create larger and more effective treatment areas, aiding in heart rhythm control. These findings suggest that SERF ablation could be a viable option for individuals with challenging VT cases. Participants in this trial will receive SERF ablation as the sole treatment under investigation. ^{1 2 5 6 7}

Who Is on the Research Team?

Michael Curley, PhD

Principal Investigator

Thermedical, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35776711/

Ablation of Refractory Ventricular Tachycardia Using ... Conclusions: Intramural heated saline needle ablation showed complete acute and satisfactory mid-term control of difficult VTs failing 1 to 5 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02994446

Saline-Enhanced Radiofrequency (SERF) Catheter ... Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia (SERF-VT) · Study Overview · Contacts and Locations.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35714882/

Evaluation of Saline-Enhanced Radiofrequency Needle ... From 43 clinical VTs induced, 42 were ablated and 266 SERF lesions were delivered (10.6 ± 4.9 per patient). Of the 42 treated clinical VTs, 41 VTs (98%) were ...

4. dicardiology.com dicardiology.com/content/saline-enhanced-radiofrequency-ablation-may-be-effective-method-treat-ventricular

Saline Enhanced Radiofrequency Ablation May be an ... Five-month follow-up data demonstrate that more than half of the patients had no recurrent VT and more than 60 percent of the patients had their ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.121.010347?doi=10.1161/CIRCEP.121.010347

Ablation of Refractory Ventricular Tachycardia Using ... Heated saline-enhanced radiofrequency (SERF) ablation has also been forwarded as a potentially more effective means of creating larger, more ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.121.010347

Ablation of Refractory Ventricular Tachycardia Using ... Intramural heated saline needle ablation showed complete acute and satisfactory mid-term control of difficult VTs failing 1 to 5 prior ablations and drug ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0828282X22003506

Evaluation of Saline-Enhanced Radiofrequency Needle ... From 43 clinical VTs induced, 42 were ablated and 266 SERF lesions were delivered (10.6 ± 4.9 per patient). Of the 42 treated clinical VTs, 41 VTs (98%) were ...