Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement

NCT04717570 | Unknown DMC FDA Device

• 1 other identifier: Foldax CP-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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

Conditions

Mitral Valve Disease; Mitral Valve Stenosis; Mitral Valve Failure

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoints

  Adverse Event (AE) rates for valve related early and late complications : thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, endocarditis, structural valve deterioration, nonstructural valve dysfunction, valve related hemolysis, all cause death, valve related reoperation, valve explant, and valve related death. Results are visually compared to event rates reported in the literature.

  12 months following patient enrollment completion

• Primary Effectiveness Endpoints- Change in Hemodynamic Performance

  Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement.

  12 months following patient enrollment completion

• Clinical Effectiveness: Change in New York Heart Association Assessment

  Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

  12 months following patient enrollment completion

Secondary Outcomes (10)

• Number of Participants with Stroke

  5 years following patient enrollment

• Number of Participants with Transient Ischemic Attack

  5 years following patient enrollment

• Number of Participants with Migration of the TRIA valve

  5 years following patient enrollment

• ICU Duration of Stay

  30 days post patient enrollment

• Ventilation Time

  30 days post patient enrollment

Study Arms (1)

TRIA Mitral Valve

EXPERIMENTAL

Patients receiving the Foldax Mitral Valve

Device: Foldax TRIA Mitral Valve

Interventions

Foldax TRIA Mitral Valve DEVICE

Mitral Valve Replacement

TRIA Mitral Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foldax, Inc: lead

Study Sites (3)

St. Vincent Hospital

Carmel, Indiana, 46260, United States

Location

Ascension Via Christi St. Francis

Wichita, Kansas, 67226, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Frank Shannon, MD

  Beaumont Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All patients will receive the study device

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 22, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)