NCT01514162CompletedNot Applicable
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Abbott Medical Devices6 sites in 1 country245 target enrollmentStarted: February 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 245
- Locations
- 6
- Primary Endpoint
- Late Adverse Event Incidence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Subject currently participating in another device or drug study
- •Subject unable or unwilling to return for study follow-up visits
Arms & Interventions
Trifecta Valve Group
Experimental
Subjects implanted with a Trifecta valve.
Intervention: Trifecta valve (Device)
Outcomes
Primary Outcomes
Late Adverse Event Incidence
Time Frame: 5 years
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]
Secondary Outcomes
- Characterize Patient NYHA Functional Classification Status(5 years)
- Report the Hemodynamic Performance of the Valve(5 years)
Investigators
Study Sites (6)
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