Medtronic Cardiac Rhythm and Heart FailureINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
50Actual
Last Update Posted
Dec 2, 2016Estimated
Start Date
May 2013
Primary Completion Date
May 2014Actual
Completion Date
Jun 2014Actual
Brief Summary
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
Ventricular Arrhythmias
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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
Subject is pregnant
Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
Observational Model
Cohort
Time Perspective
Prospective
No central contacts
There are no central contacts for this study.
Republican Scientific and Practical Center Cardiology
Minsk, Belarus
Rigshospitalet
Copenhagen, Denmark
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus MC
Rotterdam, Netherlands
Slovak Medical University
Bratislava, Slovakia 83348, Slovakia
Dudley Group NHS-Russells Hall Hospital
Dudley, United Kingdom
King's College Hospital
London, United Kingdom
Southhampton General Hospital
Southhampton, United Kingdom
Lead Sponsor
Medtronic Cardiac Rhythm and Heart FailureINDUSTRY