Mitral Valve DiseaseNCT06191718
Clinical Investigation for the Foldax Tria Mitral Valve- India
A study testing Mitral Valve Replacement in people with Mitral Valve Disease and Mitral Regurgitation, run by Foldax, Inc at 10 sites in India.
Trial summary
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitral Valve Disease, Mitral Regurgitation, Mitral Stenosis
- What is being tested?
- Mitral Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 10 sitesIndia
- Study dates
- 1 Mar 2023to 1 Dec 2024
- 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
- Healthy volunteers accepted
- 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 severe mitral valve disease
- No contraindication for anticoagulation treatment
- Willing and able to comply with protocol requirements
Who cannot join
- Requires valve replacement other than mitral
- Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
- Required concomitant cardiovascular procedures except for CABG and/or COX-MAZE if approved by the screening committee
- Requires emergency surgery
- Requires other planned surgery within 12 months of valve replacement
- Active endocarditis or active myocarditis
Show all 19Show fewer
- Exhibits left ventricular ejection fraction </= 20% as validated by diagnostic procedure prior to planned valve surgery
- Acute preoperative neurological deficit defined as neurological deficit < 3 months prior to enrollment
- 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 insufficiency as determined by creatinine (S-CR) level as >/= 2.0 mg/dl or end stage renal disease requiring chronic dialysis at screening visit
- Results for the following blood tests are not within normal limits: D-Dimer, Basic Metabolic Panel Liver enzymes, Coagulation Profile - platelets, APTT, INR, Fibrinogen, C-reactive protein (HSCRP) and ESR, and Troponin levels
- 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 pregnant or expect to become pregnant in the 12 months following implantation, or are lactating
- Any other condition that, in the judgment of the investigator and screening committee, makes the patient a poor candidate for the procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, COVID-19 related concerns)
- 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
10 sites in 1 country.
10 sites in 1 country
India10 sites
GCS Medical College
Ahmedabad, Gujarat, 380025
Epic Hospital
Ahmedabad, Gujarat, 380060
Fortis Hospital
Delhi, 110025
Indo-US Hospital
Hyderabad, Telangana, 500016
SMS Hospital
Jaipur, Rajasthan, 302004
NRS Medical College and Hospital
Kolkata, West Bengal, 700014
KEM Hospital
Mumbai, Maharashtra, 400012
Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016
Six Sigma
Nashik, Maharashtra, 422007
B.J. Medical College
Pune, Maharashtra, 411001
About this study
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance.
Read the detailed description
The Foldax Tria Mitral Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. The study is a single open are label non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 70 patients. The first two patients at each site, will be considered roll-in patients accounting for training. Up to 50 patients will be considered part of the treatment phase. These patients will follow the study schedule for 1 year after implantation.
- Being tested
- Mitral Valve Replacement
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Valve ReplacementDevice
Foldax Mitral Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Tria Mitral Valve | Experimental | Patients receiving the Foldax Mitral Valve Receives: Device: Mitral Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoints
Serious Adverse Event (SAE) rates for any valve related events. Results are compared descriptively to event rates reported in the literature.
Measured: 12 months after last patient enrollment
Primary Effectiveness Endpoint- Change in Hemodynamic Performance
Hemodynamic performance parameters are mmHG mean gradient, peak gradient, and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (mean/peak gradient and Effective Orifice Area (EOA)) at one year based on literature reports for surgical mitral valve replacement.
Measured: 12 months after last patient enrollment
Clinical Effectiveness Endpoint- 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 after last patient enrollment
Secondary outcomes (8)
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: 1 year following patient enrollment
Number of Participants with Structural Valve Deterioration (SVD)
Assessment of patient experiencing SVD as verified by imaging, procedure, or physical exam
Measured: 1 year 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: 1 year 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
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
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 posted5 Jan 2024
- Study start1 Mar 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foldax, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191718
- Sponsor's protocol ID
- CP-004
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George I, Rao DP, Jain A, Ascione G, Sharma M, Meharwal ZS, Sarkar B, Kochar N, Gan MD, Shastri N, Runt J, Whisenant B, Wilson B, Kiser A, Leon MB, Pandey K. 1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve: Insights Into New Technology. J Am Coll Cardiol. 2025 Aug 19;86(7):515-526. doi: 10.1016/j.jacc.2025.06.017. Epub 2025 Jun 27.
PubMed 40589299
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation for the Foldax Tria Mitral Valve- India
- ClinicalTrials.gov ID
- NCT06191718
- Acronym / sponsor ID
- CP-004
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Foldax, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 5 Jan 2024 (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 a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance.
Detailed description
The Foldax Tria Mitral Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. The study is a single open are label non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 70 patients. The first two patients at each site, will be considered roll-in patients accounting for training. Up to 50 patients will be considered part of the treatment phase. These patients will follow the study schedule for 1 year 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 Mitral Valve | Experimental | Device: Mitral Valve ReplacementPatients receiving the Foldax Mitral Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 severe mitral valve disease
- No contraindication for anticoagulation treatment
- Willing and able to comply with protocol requirements
Key exclusion criteria (19 listed)
- Requires valve replacement other than mitral
- Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
- Required concomitant cardiovascular procedures except for CABG and/or COX-MAZE if approved by the screening committee
- Requires emergency surgery
- Requires other planned surgery within 12 months of valve replacement
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 |
|---|---|---|
| Mitral Valve ReplacementFoldax Mitral Valve Replacement | Device | Tria Mitral Valve |
Primary outcome
Primary Safety Endpoints
Time frame: 12 months after last patient enrollment
Serious Adverse Event (SAE) rates for any valve related events. Results are compared descriptively to event rates reported in the literature.
Primary Effectiveness Endpoint- Change in Hemodynamic Performance
Time frame: 12 months after last patient enrollment
Hemodynamic performance parameters are mmHG mean gradient, peak gradient, and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (mean/peak gradient and Effective Orifice Area (EOA)) at one year based on literature reports for surgical mitral valve replacement.
Clinical Effectiveness Endpoint- Change in New York Heart Association Assessment
Time frame: 12 months after last patient enrollment
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.
8 secondary outcomes
Number of Participants with Stroke
Time frame: 1 year following patient enrollment
Number of Participants with Structural Valve Deterioration (SVD)
Time frame: 1 year following patient enrollment
Number of Participants with Transient Ischemic Attack
Time frame: 1 year following patient enrollment
ICU Duration of Stay
Time frame: 30 Days post patient enrollment
Ventilation Time
Time frame: 30 Days post patient enrollment
Post Procedure length of stay
Time frame: 30 days post patient enrollment
Kansas City Cardiomyopathy Questionnaire
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 5 Jan 2024.
- Derived from this study: PubMed 40589299George I, Rao DP, Jain A, Ascione G, Sharma M, Meharwal ZS, Sarkar B, Kochar N, Gan MD, Shastri N, Runt J, Whisenant B, Wilson B, Kiser A, Leon MB, Pandey K. 1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve: Insights Into New Technology. J Am Coll Cardiol. 2025 Aug 19;86(7):515-526. doi: 10.1016/j.jacc.2025.06.017. Epub 2025 Jun 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral Valve Replacement in people with Mitral Valve Disease and Mitral Regurgitation, run by Foldax, Inc at 10 sites in India.
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 5 inclusion and 19 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. 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 after last patient enrollment). 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?
On the ClinicalTrials.gov record for NCT06191718, which also lists 1 linked publication.
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 5 Jan 2024.