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.
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 occur at 7 days, 30 days, 3 months and 6 months. The single arm design of the proposed study reflects the nature of the study population. The Thermedical Ablation System was designated as a Breakthrough technology in part because no currently approved device specifically treats this refractory patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
The Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates
University of Alabama at Birmingham
Birmingham, Alabama, United States
NOT_YET_RECRUITINGHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
Primary Efficacy (Acute Interim)
Percentage of target clinical VTs that are non-inducible at end of the study ablation procedure (if PES performed at procedure conclusion)
Time frame: At end of ablation procedure (ablation procedure occurs on a single day)
Primary Efficacy (Long Term)
Percentage of subjects who are free from recurrent monomorphic VT
Time frame: 6 month post ablation
Primary Safety
Per subject composite of cardiovascular-related and procedure-related major complications through 7 days post-study ablation procedure
Time frame: 7 days from intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
NOT_YET_RECRUITINGIntermountain Healthcare
Salt Lake City, Utah, United States
RECRUITINGMontreal Heart Institute - Institut de Cardiologie de Montréal
Montreal, Quebec, Canada
RECRUITINGQuebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
NOT_YET_RECRUITING