Mitral Valve DiseaseFOLDAXNCT04717570
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
A study testing Foldax TRIA Mitral Valve in people with Mitral Valve Disease and Mitral Valve Stenosis, run by Foldax, Inc at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
- What is being tested?
- Foldax TRIA Mitral Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Vincent Hospital
Carmel, Indiana, 46260
The Christ Hospital
Cincinnati, Ohio, 45219
Ascension Via Christi St. Francis
Wichita, Kansas, 67226
About this study
Official title: 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.
Read the 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.
- Being tested
- Foldax TRIA Mitral Valve
- Medical subject headings
- Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foldax TRIA Mitral ValveDevice
Mitral Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| TRIA Mitral Valve | Experimental | Patients receiving the Foldax Mitral Valve Receives: Device: Foldax TRIA Mitral Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months following patient enrollment completion
Secondary outcomes (10)
Number of Participants with Stroke
Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam
Measured: 5 years following patient enrollment
Number of Participants with Transient Ischemic Attack
Assessment of patient having a TIA as verified by imaging and or physical exam
Measured: 5 years following patient enrollment
Number of Participants with Migration of the TRIA valve
Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
Measured: 5 years following patient enrollment
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.
Measured: 30 days post patient enrollment
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
Measured: 30 days post patient enrollment
New Onset Atrial Fibrillation
New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
Measured: 12 months post patient enrollment
Readmission within 30 days of discharge
Patient readmission to the hospital post discharge measured by date/time
Measured: 30 days post patient discharge date
Post Procedure length of stay
- 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.
Measured: 30 days post patient enrollment
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status.
Measured: 12 months post patient enrollment
Six Minute Walk Test
Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes
Measured: 12 months post patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive the study device
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foldax, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Shannon, MD, Study chair, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717570
- Sponsor's protocol ID
- Foldax CP-002
- Acronym
- FOLDAX
- Status last verified
- Sep 2023
- First submitted
- 14 Dec 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption
- ClinicalTrials.gov ID
- NCT04717570
- Acronym / sponsor ID
- FOLDAX / Foldax CP-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Foldax, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive the study device
| Arm | Type | Receives |
|---|---|---|
| TRIA Mitral Valve | Experimental | Device: Foldax TRIA Mitral ValvePatients receiving the Foldax Mitral Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foldax TRIA Mitral ValveMitral Valve Replacement | Device | TRIA Mitral Valve |
Primary outcome
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.
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.
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.
10 secondary outcomes
Number of Participants with Stroke
Time frame: 5 years following patient enrollment
Number of Participants with Transient Ischemic Attack
Time frame: 5 years following patient enrollment
Number of Participants with Migration of the TRIA valve
Time frame: 5 years following patient enrollment
ICU Duration of Stay
Time frame: 30 days post patient enrollment
Ventilation Time
Time frame: 30 days post patient enrollment
New Onset Atrial Fibrillation
Time frame: 12 months post patient enrollment
Readmission within 30 days of discharge
Time frame: 30 days post patient discharge date
Post Procedure length of stay
Time frame: 30 days post patient enrollment
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 12 months post patient enrollment
Six Minute Walk Test
Time frame: 12 months post patient enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Shannon, MD study chair
Beaumont Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foldax TRIA Mitral Valve in people with Mitral Valve Disease and Mitral Valve Stenosis, run by Foldax, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoints (time frame: 12 months following patient enrollment completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.