N/A
Completed N=245
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Source: ClinicalTrials.gov NCT01514162 ↗Enrolled (actual)
245
Serious AEs
15.9%
Results posted
May 2017
Primary outcomePrimary: Late Adverse Event Incidence — 7; 0; 0; 4 event/100-patient years
Summary
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
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 | — |
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. Informational only — not medical advice.