This observation study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.
This non-blinded, single-arm open-label, phase 1 pilot, acute research feasibility trial aims to demonstrate that the safety and effectiveness of Unpinning Termination (UPT) electrotherapy observed in the canine can be translated to humans and to demonstrate the safety and performance of UPT electrotherapy in the human population most likely to benefit from this therapy. This study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia (VT) catheter ablation or an indicated initial implant or device replacement of an implantable cardioverter defibrillator (ICD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
Electrotherapy comprised of standard biphasic and monophasic pacing pulses
Mercy Medical Group
Sacramento, California, United States
MercyOne Des Moines Medical Center
Des Moines, Iowa, United States
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm
Assess the safety and performance of the Cardialen External Stimulation System and safety and performance ofUPT therapy
Time frame: During study procedure
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, United States