Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve Insufficiency
Conditions
Brief 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.
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.
Interventions
DEVICEMitral Valve Replacement
Foldax Mitral Valve Replacement
Sponsors
Foldax, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 severe mitral valve disease * No contraindication for anticoagulation treatment * Willing and able to comply with protocol requirements
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoints | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Duration of Stay | 30 Days post patient enrollment | 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. |
| Ventilation Time | 30 Days post patient enrollment | Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes |
| Number of Participants with Stroke | 1 year following patient enrollment | Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam |
| Kansas City Cardiomyopathy Questionnaire | 12 months post patient enrollment | Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status. |
| Six Minute Walk Test | 12 months post patient enrollment | Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes |
| Post Procedure length of stay | 30 days post patient enrollment | 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. |
| Number of Participants with Structural Valve Deterioration (SVD) | 1 year following patient enrollment | Assessment of patient experiencing SVD as verified by imaging, procedure, or physical exam |
| Number of Participants with Transient Ischemic Attack | 1 year following patient enrollment | Assessment of patient having a TIA as verified by imaging and or physical exam |
Countries
India
Outcome results
None listed