Status:
UNKNOWN
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
Lead Sponsor:
Foldax, Inc
Conditions:
Mitral Valve Disease
Mitral Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance. The study is anticipated to co...
Detailed Description
The Foldax Polymer Mitral Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. This is a first in human study conducted unde...
Eligibility Criteria
Inclusion
- Is 18 years or older
- Is a candidate for mitral valve replacement with cardiopulmonary bypass
- Is a candidate for mitral valve replacement due to:
- Moderate to severe mitral valve stenosis,
- Moderate to severe mitral valve regurgitation, or
- Moderate to severe mixed mitral stenosis/regurgitation
- Able to withstand short term anticoagulation
- Willing and able to comply with protocol requirements
Exclusion
- Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
- Requires emergency surgery
- Requires other planned surgery within 12 months of valve replacement
- Active endocarditis or active myocarditis
- Acute preoperative neurological deficit defined as neurological deficit \< 3 months prior to enrollment
- Non-cardiac illness resulting in a life expectancy of less than 12 months
- Enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies)
- Myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment
- Aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications
- Renal or hepatic failure
- Hematological disorders, patients must not have a hematocrit of \<30%, hemoglobin \<10 g/dL, platelet count of \<100,000 cells/µL, or WBC \<4,000 cells/µL; coagulation profile must not be outside of normal limits
- Patients who are prisoners or mentally ill
- Patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating
- Has a positive test result for COVID-19 virus (baseline or preoperative)
- Patients who have withdrawn after implantation may not re-enter
- Intraoperatively it is determined that the patient anatomy is not compatible with the device.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04717570
Start Date
February 1 2021
End Date
December 1 2025
Last Update
September 13 2023
Active Locations (3)
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1
St. Vincent Hospital
Carmel, Indiana, United States, 46260
2
Ascension Via Christi St. Francis
Wichita, Kansas, United States, 67226
3
The Christ Hospital
Cincinnati, Ohio, United States, 45219