Early Feasibility Study for the Foldax Tria Aortic Heart Valve
Public ClinicalTrials.gov record NCT03851068. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.
Study identification
- NCT ID
- NCT03851068
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 40 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
- Jun 17, 2019
- Primary completion
- Nov 30, 2024
- Completion
- Nov 30, 2026
- Last update posted
- Sep 12, 2023
2019 – 2026
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Vincent Hospital | Indianapolis | Indiana | 46290 | — |
| Ascension Via Christi St. Francis Hospital | Wichita | Kansas | 67214 | — |
| William Beaumont Hospital | Detroit | Michigan | 48073 | — |
| The Christ Hospital | Cincinnati | Ohio | 84219 | — |
| OhioHealth Riverside | Columbus | Ohio | 43214 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03851068, 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 Sep 12, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03851068 live on ClinicalTrials.gov.