Trifecta™ Long Term Follow-Up (LTFU) Study
Public ClinicalTrials.gov record NCT01593917. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of the Trifecta™ aortic bioprosthetic valve. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supraannular placement in the aortic position. The Trifecta™ LTFU Study is an extension of the Trifecta™ Investigational Device Exemption (IDE) Study (NCT00475709) conducted to support United States Food and Drug Administration (FDA) approval of the Trifecta™ valve. All Trifecta™ LTFU Study subjects received Trifecta™ valve implants during participation in the Trifecta™ IDE study and subsequently consented to extended annual follow-up through 10 years under the Trifecta™ LTFU protocol.
Study identification
- NCT ID
- NCT01593917
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 329 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2012
- Primary completion
- Sep 25, 2019
- Completion
- Sep 25, 2019
- Last update posted
- Feb 10, 2025
2012 – 2019
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC University Hospital | Los Angeles | California | 90033 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Mission Health & Hospitals | Asheville | North Carolina | 28801 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Main Line Health Center/Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Intermountain Salt Lake Cardiovascular and Thoracic Surgery | Salt Lake City | Utah | 84103 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01593917, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01593917 live on ClinicalTrials.gov.