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Radiofrequency Ablation

SERF Ablation for Ventricular Tachycardia

N/A
Waitlist Available
Research Sponsored by Thermedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is at least 18 years old
Subject has recurrent symptomatic sustained (> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study ablation that meets specific criteria
Must not have
Renal dysfunction with eGFR <30 ml/min/1.73mP2
Subject with known coagulopathy or other condition likely to increase risk of a thrombotic event
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month post ablation
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with a heart condition who have tried other treatments but still have symptoms. The new treatment is a catheter that will destroy the tissue causing the problem.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the catheter insertion site, bleeding or bruising risks due to heparin use during the procedure, allergic reactions to contrast media used in imaging studies related to the ablation process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had a specific type of irregular heartbeat lasting more than 30 seconds in the past 6 months.
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I have a heart condition involving the structure of my heart.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is low, with an eGFR under 30.
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I have a condition that increases my risk of blood clots.
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I have VT without any heart disease, metabolic issues, or long QT syndrome.
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My VT cannot be treated with the study device during the mapping for ablation.
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I have the most severe form of heart failure.
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I am not allergic to medications used in heart rhythm procedures, including heparin.
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My treatment targets specific areas of my heart.
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I have a blood clot in my heart or fluid around it.
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I have a condition that increases my risk of bleeding during procedures.
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I have a heart defect, but it's not PFO.
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I have a severe heart valve problem.
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I do not have untreated heart disease, a recent illness, or an active infection.
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I need or am planning to get a device to help my heart pump blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month post ablation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month post ablation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy (Acute Interim)
Primary Efficacy (Long Term)
Secondary study objectives
Primary Safety
Other study objectives
Secondary Efficacy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Thermedical, Inc.Lead Sponsor
2 Previous Clinical Trials
41 Total Patients Enrolled
Trena DepelStudy DirectorThermedical, Inc.
Michael Curley, PhDStudy DirectorThermedical, Inc.

Media Library

Saline Enhanced Radiofrequency (SERF) Ablation (Radiofrequency Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT05337241 — N/A
irregular heartbeats Research Study Groups: Single arm treatment
irregular heartbeats Clinical Trial 2023: Saline Enhanced Radiofrequency (SERF) Ablation Highlights & Side Effects. Trial Name: NCT05337241 — N/A
Saline Enhanced Radiofrequency (SERF) Ablation (Radiofrequency Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05337241 — N/A
~87 spots leftby Jun 2027
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