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

September 11, 2023 updated by: Foldax, Inc

Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46260
        • St. Vincent Hospital
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Ascension Via Christi St. Francis
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TRIA Mitral Valve
Patients receiving the Foldax Mitral Valve
Device: Foldax TRIA Mitral Valve
Mitral Valve Replacement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoints
Time Frame: 12 months following patient enrollment completion
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
Time Frame: 12 months following patient enrollment completion
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
Time Frame: 12 months following patient enrollment completion
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Stroke
Time Frame: 5 years following patient enrollment
Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam
5 years following patient enrollment
Number of Participants with Transient Ischemic Attack
Time Frame: 5 years following patient enrollment
Assessment of patient having a TIA as verified by imaging and or physical exam
5 years following patient enrollment
Number of Participants with Migration of the TRIA valve
Time Frame: 5 years following patient enrollment
Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
5 years following patient enrollment
ICU Duration of Stay
Time Frame: 30 days post patient enrollment
Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes.
30 days post patient enrollment
Ventilation Time
Time Frame: 30 days post patient enrollment
Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes
30 days post patient enrollment
New Onset Atrial Fibrillation
Time Frame: 12 months post patient enrollment
New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
12 months post patient enrollment
Readmission within 30 days of discharge
Time Frame: 30 days post patient discharge date
Patient readmission to the hospital post discharge measured by date/time
30 days post patient discharge date
Post Procedure length of stay
Time Frame: 30 days post patient enrollment
l. Post procedure length of stay defined as the time/date documented for arrival in the recovery unit to date/ time of discharge in hours and minutes.
30 days post patient enrollment
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 12 months post patient enrollment
Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status.
12 months post patient enrollment
Six Minute Walk Test
Time Frame: 12 months post patient enrollment
Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes
12 months post patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foldax, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Frank Shannon, MD, Beaumont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Foldax CP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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