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Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Primary Purpose

Aortic Valve Disease, Aortic Valve Stenosis

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Foldax Tria Aortic Valve

About this trial

This is an interventional treatment trial for Aortic Valve Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Is 18 years or older
Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial
Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

Exclusion Criteria:

Requires multiple valve replacement / repair
Requires emergency surgery
Has had prior valve surgery
Requires a surgical procedure outside of the cardiac area
Requires a cardiac procedure other than a CABG or root enlargement
Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device
Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit
Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery
Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery
Has life expectancy to less than 12 months
Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
Echocardiographic left ventricular ejection fraction <25%
Echocardiographic evidence of an intra-cardiac thrombus or vegetation
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy
Has prior organ transplant or is currently an organ transplant candidate
Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
Pregnant, lactating or planning to become pregnant during the duration of participation in trial
Currently incarcerated or unable to give voluntary informed consent
Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Sites / Locations

St. Vincent Hospital
Ascension Via Christi St. Francis Hospital
William Beaumont Hospital
The Christ Hospital
OhioHealth Riverside

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tria Aortic Valve

Arm Description

Patients receiving the Foldax Tria Aortic Valve

Outcomes

Primary Outcome Measures

Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments

The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis

Primary Safety Endpoints: Surgical Valve Events Rate Assessment

The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death

Primary Effectiveness Endpoint: Hemodynamic Performance Assessment

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.

Primary Effectiveness Endpoint: New York Heart Association Improvement 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.

Secondary Outcome Measures

Secondary Endpoints: Stroke

Assessment of patient experiencing a stroke verified by imaging and or physical exam

Secondary Endpoint: Transient Ischemic Attack

Assessment of patient having a TIA verified by imaging and or physical exam

Secondary Endpoint: ICU Duration of Stay

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.

Secondary Endpoint: Ventilation Time

Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes

Secondary Endpoint: New Onset Atrial Fibrillation

New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review

Secondary Endpoint: Length of Stay in Hospital

Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes.

Secondary Endpoint: Readmission

Patient readmission to the hospital post discharge measured by date/time

Secondary Endpoint: Hemolysis screen

Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments

Secondary Endpoint: Change in Quality of Life (QOL)

Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire

Full Information

NCT ID

NCT03851068

First Posted

February 14, 2019

Last Updated

September 11, 2023

Sponsor

Foldax, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03851068

Brief Title

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Official Title

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 18, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Foldax, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic 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.

Detailed Description

The Foldax Polymer Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic 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 40 patients. These patients will be followed up to 5 years after implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Disease, Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tria Aortic Valve

Arm Type

Experimental

Arm Description

Patients receiving the Foldax Tria Aortic Valve

Intervention Type

Device

Intervention Name(s)

Foldax Tria Aortic Valve

Intervention Description

Aortic Valve Replacement

Primary Outcome Measure Information:

Title

Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments

Description

Time Frame

12 months following patient enrollment completion

Title

Primary Safety Endpoints: Surgical Valve Events Rate Assessment

Description

Time Frame

12 months following patient enrollment completion

Title

Primary Effectiveness Endpoint: Hemodynamic Performance Assessment

Description

Time Frame

12 months following patient enrollment completion

Title

Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment

Description

Time Frame

12 months following patient enrollment completion

Secondary Outcome Measure Information:

Title

Secondary Endpoints: Stroke

Description

Assessment of patient experiencing a stroke verified by imaging and or physical exam

Time Frame

5 years following patient enrollment

Title

Secondary Endpoint: Transient Ischemic Attack

Description

Assessment of patient having a TIA verified by imaging and or physical exam

Time Frame

5 Years following patient enrollment

Title

Secondary Endpoint: ICU Duration of Stay

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.

Time Frame

30 days post procedure

Title

Secondary Endpoint: Ventilation Time

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

Time Frame

30 Days post procedure

Title

Secondary Endpoint: New Onset Atrial Fibrillation

Description

New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review

Time Frame

12 Months post procedure

Title

Secondary Endpoint: Length of Stay in Hospital

Description

Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes.

Time Frame

30 days post procedure

Title

Secondary Endpoint: Readmission

Description

Patient readmission to the hospital post discharge measured by date/time

Time Frame

30 days post discharge

Title

Secondary Endpoint: Hemolysis screen

Description

Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments

Time Frame

12 months post procedure

Title

Secondary Endpoint: Change in Quality of Life (QOL)

Description

Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire

Time Frame

12 months post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is 18 years or older Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations Exclusion Criteria: Requires multiple valve replacement / repair Requires emergency surgery Has had prior valve surgery Requires a surgical procedure outside of the cardiac area Requires a cardiac procedure other than a CABG or root enlargement Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device Has active endocarditis/myocarditis or within 3 months to the scheduled surgery Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery Has life expectancy to less than 12 months Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism Echocardiographic left ventricular ejection fraction <25% Echocardiographic evidence of an intra-cardiac thrombus or vegetation Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy Has prior organ transplant or is currently an organ transplant candidate Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial Pregnant, lactating or planning to become pregnant during the duration of participation in trial Currently incarcerated or unable to give voluntary informed consent Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Shannon, MD

Organizational Affiliation

Beaumont Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Vincent Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Ascension Via Christi St. Francis Hospital

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

William Beaumont Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

The Christ Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

84219

Country

United States

Facility Name

OhioHealth Riverside

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

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