Aortic Valve DiseaseNCT03851068
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
A study testing Foldax Tria Aortic Valve in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Foldax, Inc at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis
- What is being tested?
- Foldax Tria Aortic Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jun 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Christ Hospital
Cincinnati, Ohio, 84219
OhioHealth Riverside
Columbus, Ohio, 43214
William Beaumont Hospital
Detroit, Michigan, 48073
St. Vincent Hospital
Indianapolis, Indiana, 46290
Ascension Via Christi St. Francis Hospital
Wichita, Kansas, 67214
About this study
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.
Read the 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.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Being tested
- Foldax Tria Aortic Valve
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foldax Tria Aortic ValveDevice
Aortic Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Tria Aortic Valve | Experimental | Patients receiving the Foldax Tria Aortic Valve Receives: Device: Foldax Tria Aortic Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months following patient enrollment completion
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
Measured: 12 months following patient enrollment completion
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.
Measured: 12 months following patient enrollment completion
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.
Measured: 12 months following patient enrollment completion
Secondary outcomes (9)
Secondary Endpoints: Stroke
Assessment of patient experiencing a stroke verified by imaging and or physical exam
Measured: 5 years following patient enrollment
Secondary Endpoint: Transient Ischemic Attack
Assessment of patient having a TIA verified by imaging and or physical exam
Measured: 5 Years following patient enrollment
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.
Measured: 30 days post procedure
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
Measured: 30 Days post procedure
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
Measured: 12 Months post procedure
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.
Measured: 30 days post procedure
Secondary Endpoint: Readmission
Patient readmission to the hospital post discharge measured by date/time
Measured: 30 days post discharge
Secondary Endpoint: Hemolysis screen
Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments
Measured: 12 months post procedure
Secondary Endpoint: Change in Quality of Life (QOL)
Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start18 Jun 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foldax, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Shannon, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851068
- Sponsor's protocol ID
- FOLDAX CP-001
- Status last verified
- Sep 2023
- First submitted
- 14 Feb 2019
- 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 Aortic Heart Valve
- ClinicalTrials.gov ID
- NCT03851068
- Acronym / sponsor ID
- FOLDAX CP-001
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foldax, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Feb 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tria Aortic Valve | Experimental | Device: Foldax Tria Aortic ValvePatients receiving the Foldax Tria Aortic Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
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 Aortic ValveAortic Valve Replacement | Device | Tria Aortic Valve |
Primary outcome
Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments
Time frame: 12 months following patient enrollment completion
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
Time frame: 12 months following patient enrollment completion
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
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.
Primary Effectiveness Endpoint: New York Heart Association Improvement 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.
9 secondary outcomes
Secondary Endpoints: Stroke
Time frame: 5 years following patient enrollment
Secondary Endpoint: Transient Ischemic Attack
Time frame: 5 Years following patient enrollment
Secondary Endpoint: ICU Duration of Stay
Time frame: 30 days post procedure
Secondary Endpoint: Ventilation Time
Time frame: 30 Days post procedure
Secondary Endpoint: New Onset Atrial Fibrillation
Time frame: 12 Months post procedure
Secondary Endpoint: Length of Stay in Hospital
Time frame: 30 days post procedure
Secondary Endpoint: Readmission
Time frame: 30 days post discharge
Secondary Endpoint: Hemolysis screen
Time frame: 12 months post procedure
Secondary Endpoint: Change in Quality of Life (QOL)
Time frame: 12 months post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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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 principal investigator
Beaumont Hospital
5 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 Aortic Valve in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Foldax, Inc at 5 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 4 inclusion and 24 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: under way, not looking for participants, 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 5 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?
This study is still under way. Results are not available in the source record yet.
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: Objective Performance Criteria for Flexible Heart Valve Events Assessments (time frame: 12 months following patient enrollment completion). The study lists 4 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.