Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
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 ablat
| Condition(s) | Refractory Ventricular Tachycardia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria: 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 t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Thermedical, Inc. |
| Locations | Birmingham, Alabama, United States; Philadelphia, Pennsylvania, United States; Charleston, South Carolina, United States; Nashville, Tennessee, United States; Salt Lake City, Utah, United States; Montreal, Quebec, Canada (+1 more sites) |
| Start date | 2025-08-09 |
| NCT ID | NCT05337241 |
| Official listing | https://clinicaltrials.gov/study/NCT05337241 |