Ventricular Tachycardia
Conditions
Keywords
Termination, Unpinning, Therapy
Brief summary
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.
Detailed description
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).
Interventions
Electrotherapy comprised of standard biphasic and monophasic pacing pulses
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Cardialen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Patients undergoing a routine clinically indicated procedure will have the investigational therapy delivered during the clinically indicated procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The subject must meet all of the following inclusion criteria: 1. Life expectancy of 1 year or greater 2. Male or female between 18 and 80 years of age 3. Willing and able to comply with the study protocol, provide a written informed consent 4. 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) 5. Etiology of arrhythmia, or risk of arrhythmia being ischemic cardiomyopathy or non-ischemic cardiomyopathy 6. Medically stable at time of consent to undergo DFT testing performed under general anesthesia or conscious sedation as determined by the investigator
Exclusion criteria
The subject must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm | During study procedure | Assess the safety and performance of the Cardialen External Stimulation System and safety and performance ofUPT therapy |
Countries
United States
Outcome results
None listed