Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement (FOLDAX)

Foldax

Status

Active, not recruiting

Conditions

Mitral Valve Failure

Mitral Valve Disease

Mitral Valve Stenosis

Treatments

Device: Foldax TRIA Mitral Valve

Study type

Interventional

Funder types

Industry

Identifiers

NCT04717570

Foldax CP-002

Details and patient eligibility

About

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 confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Full 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 under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 15 patients. These patients will be followed up to 5 years after implantation.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.