Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
United States130 participantsStarted 2025-08-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has structural heart disease
✓. Subject has recurrent symptomatic sustained (\> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study ablation that meets the following criteria:
✓. 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
✓. Documentation of the presumed recurrent MMVT was treated with prior catheter ablation AND
✓. 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
✓. 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.
✓. Subject is at least 18 years old
✓. Subject has an implantable cardioverter-defibrillator (ICD) with a full 6-month (prior to planned study ablation) ICD interrogation history documenting incidences of VT
Exclusion criteria
✕. 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)
✕. Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum
What they're measuring
1
Primary Efficacy (Acute Interim)
Timeframe: At end of ablation procedure (ablation procedure occurs on a single day)