NCT01771172
Completed
Not Applicable
Acute Subcutaneous Defibrillation
Medtronic Cardiac Rhythm and Heart Failure8 sites in 5 countries50 target enrollmentMay 2013
ConditionsVentricular Arrhythmias
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventricular Arrhythmias
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 50
- Locations
- 8
- Primary Endpoint
- Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must be undergoing implant of a commercially approved ICD system
- •Subject must be willing to provide Informed Consent
- •Subject must be \> 18 years old
Exclusion Criteria
- •Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate \< 29 mls/min/1.73m2 (recorded in the last six months)
- •Subject has high risk of infection
- •Subject has EF \< 15%
- •Subject at high risk of stroke
- •having a device replacement
- •Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
- •Subject is indicated for CRT
- •Subject is pacemaker dependent
- •Subject enrolled in a concurrent study that may confound the results of this study
- •Subject has medical conditions that would limit study participation
Outcomes
Primary Outcomes
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
Time Frame: within the first day
Study Sites (8)
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