Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
Thermedical, Inc.
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.
Description
This is a staged, non-randomized, open-label, single group, interventional study to be conducted at up to 25 investigational sites to evaluate the safety and efficacy of the Thermedical Ablation System with the Durablate Ablation Catheter (investigational device) in subjects with recurrent, sustained, monomorphic ventricular tachycardia (VT) refractory to drug therapy and conventional catheter ablation. Subjects will be consented (enrolled) and screened prior to the study ablation procedure. 154 subjects will have a study ablation procedure with the investigational device. Follow-up will occu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 I…
Interventions
- DeviceSaline Enhanced Radiofrequency (SERF) Ablation
The Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates
Locations (7)
- University of Alabama at BirminghamBirmingham, Alabama
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
- Medical University of South CarolinaCharleston, South Carolina
- Vanderbilt University Medical CenterNashville, Tennessee
- Intermountain HealthcareSalt Lake City, Utah
- Montreal Heart Institute - Institut de Cardiologie de MontréalMontreal, Quebec