Carmel, Indiana 46260

  • Mitral Valve Failure

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

Foldax CP-002


NCT ID:

NCT04717570


Secondary ID:


Study Acronym:

FOLDAX


Brief Title:

Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Foldax, Inc


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Frank Shannon, MD
Study Chair
Beaumont Hospital
Primary Contact:Carlyn Sander, BS, BSN
352-359-2355
carlyn.sander@foldax.com

Study Dates

Start Date:February 1, 2021
Completion Date:December 2025
Completion Type:Anticipated
Primary Completion Date:December 2021
Primary Completion Type:Anticipated
Verification Date:February 2021
Last Changed Date:February 5, 2021
First Received Date:December 14, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Primary Safety Endpoints
Time Frame:12 months following patient enrollment completion
Safety Issues:False
Description: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,
Outcome Type:Primary Outcome
Measure:Primary Effectiveness Endpoints- Change in Hemodynamic Performance
Time Frame:12 months following patient enrollment completion
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Clinical Effectiveness: Change in New York Heart Association Assessment
Time Frame:12 months following patient enrollment completion
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Number of Participants with Stroke
Time Frame:5 years following patient enrollment
Safety Issues:False
Description:Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam
Outcome Type:Secondary Outcome
Measure:Number of Participants with Transient Ischemic Attack
Time Frame:5 years following patient enrollment
Safety Issues:False
Description:Assessment of patient having a TIA as verified by imaging and or physical exam
Outcome Type:Secondary Outcome
Measure:Number of Participants with Migration of the TRIA valve
Time Frame:5 years following patient enrollment
Safety Issues:False
Description:Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
Outcome Type:Secondary Outcome
Measure:ICU Duration of Stay
Time Frame:30 days post patient enrollment
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Ventilation Time
Time Frame:30 days post patient enrollment
Safety Issues:False
Description:Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes
Outcome Type:Secondary Outcome
Measure:New Onset Atrial Fibrillation
Time Frame:12 months post patient enrollment
Safety Issues:False
Description:New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
Outcome Type:Secondary Outcome
Measure:Readmission within 30 days of discharge
Time Frame:30 days post patient discharge date
Safety Issues:False
Description:Patient readmission to the hospital post discharge measured by date/time
Outcome Type:Secondary Outcome
Measure:Post Procedure length of stay
Time Frame:30 days post patient enrollment
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame:12 months post patient enrollment
Safety Issues:False
Description:Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status.
Outcome Type:Secondary Outcome
Measure:Six Minute Walk Test
Time Frame:12 months post patient enrollment
Safety Issues:False
Description:Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes

Study Interventions

Intervention Type:Device
Name:Foldax TRIA Mitral Valve
Description:Mitral Valve Replacement
Arm Name:TRIA Mitral Valve

Study Arms

Study Arm Type:Experimental
Arm Name:TRIA Mitral Valve
Description:Patients receiving the Foldax Mitral Valve

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Foldax, Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 28, 2021

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