In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Cardiology
Title
Product Performance Platform
Description
Subjects on this study will be screened and consented within 30 days of implantation of their cardiac device. Subjects receiving a defibrillator (ICD) or heart failure device (CRT) will have in-office follow.
IRB Number
Pro1945
Inclusion/Notes
INCLUSION:
Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
Subject is implanted or is intended to be implanted with at least one Medtronic market-released product used for pacing, sensing or defibrillation application.
Subject within 30 days of implant or subject participated in the pre-market study phase for the product now enrolling in the PPP in which case the subject can be enrolled retrospectively (implant day is defined as day 0).
EXCLUSION:
Subject who is, or will be inaccessible for follow-up at site.
Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only).
Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable (Section 3.5.1details minimum data requirements for eligibility).
Subject implanted with Medtronic market-released product but all implanted products are closed to enrollment per the Enrollment Guide.
