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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month post ablation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month post ablation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month post ablation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy (Acute Interim)
Primary Efficacy (Long Term)
Secondary outcome measures
Primary Safety
Other outcome measures
Secondary Efficacy
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.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.I have VT without any heart disease, metabolic issues, or long QT syndrome.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.My VT cannot be treated with the study device during the mapping for ablation.I have atrial fibrillation/flutter and haven't been on continuous blood thinners for 3 weeks before my ablation.You are expected to live for less than 1 year.I have had a specific type of irregular heartbeat lasting more than 30 seconds in the past 6 months.I have the most severe form of heart failure.You have a device in your body to block the left atrial appendage.I am not allergic to medications used in heart rhythm procedures, including heparin.I have had a heart attack or unstable chest pain in the last 3 months.I am not pregnant, either through menopause or a negative pregnancy test.I have a heart condition involving the structure of my heart.My treatment targets specific areas of my heart.Your heart's pumping function is very weak, as shown in the imaging before the procedure.I had heart surgery or a procedure to open my heart arteries within the last 3 months.I have a blood clot in my heart or fluid around it.I have a condition that increases my risk of bleeding during procedures.I have a heart defect, but it's not PFO.You are planning to use a catheter that is not part of the study.I have a severe heart valve problem.I do not have untreated heart disease, a recent illness, or an active infection.I am willing and able to follow all study procedures and requirements.You have a mechanical aortic valve, mechanical mitral valve, or have had a MitraClip procedure.I had a tumor ablation less than 4 weeks ago.I need or am planning to get a device to help my heart pump blood.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to enroll in this experiment at present?
"The clinicaltrials.gov website reveals that this research project, which was first uploaded on November 1st 2022, is not currently accepting patients. Nevertheless, there are 122 additional trials open to participants at the moment."
Answered by AI
Are there any American healthcare facilities currently undertaking this research?
"Currently, this trial is enrolling participants at 9 different sites. These places are situated in Nashville, Rochester and Birmingham alongside 6 other cities. To lessen any travel needs during the study period, it's recommended to choose a site closest to you when registering."
Answered by AI
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