Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Foldax TRIA Mitral Valve: Open Heart Surgery: The total duration of the study is 18 months.
The Foldax TRIA Mitral Valve is a prosthetic heart valve with a flexible polymer stent and an
Sponsors
FOLDAX INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1) 18 years or older 2) Is a candidate for mitral valve replacement with cardiopulmonary bypass 3) Is a candidate for mitral valve replacement due to severe mitral valve disease 4) No contraindication for anticoagulation treatment 5) Willing and able to comply with protocol requirements and are willing and able to consent for the study
Exclusion criteria
Exclusion criteria: 1) Requires valve replacement other than mitral 2) Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e., Mitraclip,) 3) Required concomitant cardiovascular procedures except for CABG and/or COXMAZE if approved by the screening committee 4) Requires emergency surgery 5) Requires other planned surgery within 12 months of valve replacement 6) Active endocarditis or active myocarditis 7) Exhibits left ventricular ejection fraction = 20% as validated by diagnostic c procedure prior to planned valve surgery 8) Acute preoperative neurological deficit defined as neurological deficit to enrollment 9) Life expectancy of less than 12 months 10) Enrolled in another investigational device or drug studies (enrolled patients may not enroll in other studies) 11) Myocardial infarction, or severe cardiac adverse event who have not returned to baseline for at least 30-days prior to enrollment 12) Aortic aneurysm measuring > 4.5cm or other medical condition that creates a higher than usual risk of surgical complications 13) Has 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 14)Results for the following blood tests are not within normal limits: DDimer, Basic Metabolic Panel Liver enzymes, Coagulation Profile – platelets, APTT, INR, Fibrinogen, C-reactive protein (HSCRP) and ESR, and Troponin levels 15) Hematological disorders, patients must not have a hematocrit of cells/thrombocytosis (platelet count >450x103/µL, or history of bleeding diathesis or coagulopathy 16) Patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating 17) Any other condition that, in the judgement 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) 18) Patients who have withdrawn after implantation may not re-enter 19) Intraoperatively it is determined that the patient anatomy is not compatible with the device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Effectiveness Endpoints 1. Improved Hemodynamic Performance from Baseline as measured by echocardiographic evaluation of: a. Mean Gradient (mmHg) b. Peak Gradient (mmHg)Effective Orifice Area (EOA) (cm2) EOA Index (EOAI) (EOA cm2 /Body Area m2) c. Performance Index (PI) (PI - EOAcm2 /pre-implant tissue annulus area cm2) d. Valvular Regurgitation including paravalvular leak e. Cardiac Output (l/min) f. Cardiac Index (L/min/m2) Timepoint: 30 days(± 7 days) 90 days(± 14 days) 180 days(± 30 days) 365 days(± 45 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Secondary Endpoints provide information on health consequences: 1. Ischemic or Hemorrhagic Stroke 2. Structural Valve Deterioration (SVD) of the TRIA Mitral valve 3. Transient ischemic attack (TIA): episode of neurological dysfunction lasting 24 hours and resulting from cerebral ischemia not associated with permanent cerebral infarction. 4. ICU duration of stay. 5. Ventilation time in hours defined as arrival time/date in recovery to date and time extubated in hours and minutes. 6. 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. 7. Kansas City Cardiomyopathy Questionnaire 8. Six-Minute Walk TestTimepoint: 30 days(± 7 days) 90 days(± 14 days) 180 days(± 30 days) 365 days(± 45 days) | — |
Countries
India
Contacts
Public ContactDr Manisha Jadhav
FOLDAX India Pvt Ltd
Outcome results
None listed