N/A
N=245
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Heart Valve Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01514162 ↗Enrolled (actual)
245
Serious AEs
15.9%
Results posted
May 2017
Primary outcome: Primary: Late Adverse Event Incidence — 7; 0; 0; 4 event/100-patient years
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trifecta valve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Late Adverse Event Incidence |
7; 0; 0; 4; 9; 0 | — |
| SECONDARY Characterize Patient NYHA Functional Classification Status |
171; 16; 2; 0 | — |
| SECONDARY Report the Hemodynamic Performance of the Valve |
15.4; 10.4; 9.2; 7.9; 8.4; 6.1 | — |
Summary
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01514162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.