Status:
COMPLETED
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Subject currently participating in another device or drug study
- Subject unable or unwilling to return for study follow-up visits
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT01514162
Start Date
February 1 2012
End Date
October 1 2014
Last Update
February 15 2019
Active Locations (6)
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1
Abbott Northwestern Hospital Cardiac Surgical Associates
Minneapolis, Minnesota, United States, 55407
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Mission Hospital
Asheville, North Carolina, United States, 28801
4
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104