RecruitingRefractory Ventricular Tachycardia
Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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.
Sponsor: Thermedical, Inc.
You may qualify if…
- ✓ 1. Subject has structural heart disease
- ✓ 2. Subject has recurrent symptomatic sustained (\> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study ablation that meets the following criteria:
- ✓ 1. At least 3 episodes of the MMVT have been treated with ATP and/or shock, OR at least 2 episodes were treated with shock AND
- ✓ 2. Documentation of the presumed recurrent MMVT was treated with prior catheter ablation AND
- ✓ 3. Occurred despite treatment with at least one Class III antiarrhythmic after last ablation or treatment with a Class III antiarrhythmic is not tolerated or is contraindicated AND
- ✓ 4. VT has recurred despite VT ablation at one of the investigational centers UORU the investigator documents the reason that the subject is unlikely to benefit from a repeat ablation using a conventional, approved catheter.
- ✓ 3. Subject is at least 18 years old
- ✓ 4. Subject has an implantable cardioverter-defibrillator (ICD) with a full 6-month (prior to planned study ablation) ICD interrogation history documenting incidences of VT
You may not qualify if…
- ✕ 1. Idiopathic VT (VT occurring in subjects without structural heart disease \[including the absence of LGE on MRI, if performed\], metabolic abnormalities or long QT syndrome)
- ✕ 2. Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum
- ✕ 3. Subject with a prior ablation within 4 weeks of planned study ablation
- ✕ 4. Subject's VT is not amenable to treatment with the study device at the time of mapping for the study ablation
- ✕ 5. Only PVCs are induced during mapping for the study ablation
- ✕ 6. No clinical VT induced during mapping for the study ablation
- ✕ 7. Planned use of a non-study ablation catheter
- ✕ 8. Subject has an LVEF \< 20% reported on pre-ablation imaging (CT, MRI or echocardiogram within 48 hours of the study procedure)
Where it's recruiting
Alabama
Birmingham
Pennsylvania
Philadelphia
South Carolina
Charleston
Tennessee
Nashville
Utah
Salt Lake City
Source: ClinicalTrials.gov · NCT05337241 · last updated 2025-08-14