This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.
The purpose of this study is to gather information on the technical feasiability and safety of a needle ablation catheter called the Durablate™ Saline Enhanced Radiofrequency (SERF) catheter. This catheter is being studied to treat ventricular tachycardia (VT) in patients who have already been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an ablation procedure to treat their VT but continue to experience VT despite these treatments. A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT and applying energy with the tip of an ablation catheter to the area to create a scar or destroy the tissue that causes the VT. The SERF catheter being used in this study uses a needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart tissue that is causing the VT than a standard ablation catheter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
Loyola University Medical Center
Maywood, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Vanderbilt Heart
Nashville, Tennessee, United States
EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure.
Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success).
Time frame: By the end of the procedure
SAFETY: SAEs that are probably or definitely device related within 30 days
Time frame: within 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.