Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Completed · Not applicable

Conditions studied: Heart Valve Diseases

In brief

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

Key facts

Study ID

NCT01514162

Run by

Abbott Medical Devices

People needed

245

Starts

2012-02-01

Expected to finish

2014-10-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify if…

• Subject currently participating in another device or drug study
• Subject unable or unwilling to return for study follow-up visits

Where it is running

• Abbott Northwestern Hospital Cardiac Surgical Associates — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mission Hospital — Asheville, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt Heart Institute — Nashville, Tennessee, United States
• Intermountain Heart & Lung Surgical Associates — Murray, Utah, United States

Full record on ClinicalTrials.gov

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