Actively Recruiting
Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
Led by Thermedical, Inc. · Updated on 2025-08-14
130
Participants Needed
7
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has structural heart disease
- Subject has recurrent symptomatic sustained (> 30 seconds) monomorphic ventricular tachycardia within 180 days prior to planned study ablation
- At least 3 episodes treated with ATP and/or shock, OR at least 2 episodes treated with shock
- Documentation of prior catheter ablation for recurrent VT
- VT occurred despite treatment with at least one Class III antiarrhythmic after last ablation, or Class III antiarrhythmic is not tolerated or contraindicated
- VT recurred despite VT ablation at investigational centers or investigator documents unlikely benefit from repeat ablation with conventional catheter
- Subject is at least 18 years old
- Subject has an implantable cardioverter-defibrillator with a full 6-month ICD interrogation history documenting VT
- Subject is able to provide informed consent
You will not qualify if you...
- Idiopathic VT without structural heart disease, metabolic abnormalities, or long QT syndrome
- Suspected ablation target outside left ventricle except ventricular septum
- Prior ablation within 4 weeks of planned study ablation
- VT not treatable with study device at mapping
- Only PVCs induced during mapping
- No clinical VT induced during mapping
- Planned use of non-study ablation catheter
- Left ventricular ejection fraction less than 20% on recent imaging
- Intracardiac thrombus or pericardial effusion except chronic trivial
- Atrial fibrillation/flutter without uninterrupted anticoagulation for at least 3 weeks before procedure
- NYHA Class IV heart failure
- Renal dysfunction with eGFR less than 30 ml/min/1.73m2
- Known coagulopathy or conditions increasing bleeding or thrombotic risk
- Mechanical aortic or mitral valve, or MitraClip
- Flail mitral leaflet or severe aortic stenosis
- Left atrial appendage occlusion device
- Congenital heart defect except patent foramen ovale
- Life expectancy less than 1 year
- Myocardial infarction or unstable angina within 90 days
- Cardiac surgery or percutaneous coronary intervention within 90 days
- Untreated significant ischemic coronary artery disease, acute illness unrelated to VT, or active systemic infection
- Planned or required left ventricular assist device
- Female who is or may be pregnant (must be post-menopausal or have negative pregnancy test)
- Allergy or contraindication to medications used during ablation including heparin and ionic contrast media
- Contraindication to cardiac CT
- Concurrent enrollment in other investigational drug or device study interfering with results
- Condition or circumstance posing unacceptable risk or interfering with study participation
- Unwilling or unable to participate in all study procedures and follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
5
Intermountain Healthcare
Salt Lake City, Utah, United States, 84124
Actively Recruiting
6
Montreal Heart Institute - Institut de Cardiologie de Montréal
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
7
Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
Not Yet Recruiting
Research Team
M
Michael Curley, PhD
CONTACT
M
Mary DeVoe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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