A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT
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.
• The subject must meet all of the following inclusion criteria:
• Life expectancy of 1 year or greater
• Male or female between 18 and 80 years of age
• Willing and able to comply with the study protocol, provide a written informed consent
• Indication for an endocardial VT catheter ablation for symptomatic VT with use of CESS V1.0 or CESS V1.1 OR an indication for an ICD procedure (de novo implant, replacement or upgrade) or de novo CRTD procedure for the risk of or presence of VT (CESS 1.0 and 1.1)
• Etiology of arrhythmia, or risk of arrhythmia being ischemic cardiomyopathy or non-ischemic cardiomyopathy
• Medically stable at time of consent to undergo DFT testing performed under general anesthesia or conscious sedation as determined by the investigator