Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
Termination, Unpinning, Therapy
Brief summary
This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is hypothesized to be effective in stopping these dangerous heart rhythms at lower voltages and energy than current defibrillators. Consequently, UPT may improve survival, reduce patient pain from shocks, and lead to longer lasting and smaller implantable defibrillators.
Detailed description
A prospective single-arm feasibility study involving acute testing of UPT electrotherapy in subjects with VT/VF during clinically indicated ventricular tachycardia catheter ablation procedure or indicated implantable cardioverter defibrillator implant, upgrade, or replacement or new CRT-D implant or upgrade to CRT-D. The study involves up to two roll in subjects at each participating site followed by an UPT evaluation and refinement segment in which remaining subjects are enrolled until arrhythmia terminations from UPT delivery are reliably achieved. A prospective evaluation segment will be performed to compare UPT against SBS and ATP if sufficient subjects remain once reliable terminations from UPT are achieved. Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.
Interventions
The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen Unpinning Therapy (UPT) therapy. The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
Sponsors
Genae
Five Corners
Cardialen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Non-randomized, non-blinded, prospective, single-arm, acute, early-feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Life expectancy of 1 year or greater 2. Male or female between 18 and 75 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 sustained, life-threatening monomorphic VT OR an indication for VF and ICD implant (de novo implant, replacement or upgrade) OR CRT-D (de novo implant, upgrade from ICD) with transvenous leads for the risk of or presence of VT and/or VF. 5. Etiology of arrhythmia, or risk of arrhythmia being ischemic dilated cardiomyopathy or non-ischemic idiopathic dilated cardiomyopathy both with LVEF ≤ 35% and meeting local standard of care 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 |
|---|---|---|
| Safety of UPT therapy | Study procedure and 30 day post procedure | Adverse events |
| Parameters at which UPT terminates VT and VF | Study procedure | Voltage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voltage at which UPT and endocardial single biphasic shock terminate VT/VF | Study procedure | Voltage |
| Voltage at which UPT and ATP terminate VT | Study procedure | Voltage |
Countries
Australia
Outcome results
None listed