Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
Subject met eligibility criteria of IDE study
Subject agrees to complete study follow-up visits
Subject provides written informed consent
You may not be if
Subject currently participating in another device or drug study
Subject unable or unwilling to return for study follow-up visits
Clareo Health | Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
