Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device according to current guidelines and/or center's current practice
Subject is willing and capable (or appropriate legal representative is willing and capable) of authorizing access to and use of health information as required by an Institution's Institutional Review Board (IRB), Research Ethics Board (REB) or Ethics Committee (EC)
Is willing and capable (or appropriate legal representative is willing and capable) of providing authorization/consent for participation in the study.
You may not be if
Subject is unable or unwilling to comply with the study protocol requirements
Subject is under the legal age for signing study consent in accordance with state or national law
Subject has a life expectancy of less than twelve months
Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician's discretion)
Subject on active heart transplant list
Subject with any prior pulse generator infection or lead infection which is either systemic or localized
Subject received a commercially available Boston Scientific ICD or CRT-D device with a battery capacity of 1.5 amp/hour or less
Subject implanted with Boston Scientific's subcutaneous implantable defibrillator system (s-ICD) or has a lead that is under recall/advisory at the time of enrollment
