Status:
UNKNOWN
Clinical Investigation for the Foldax Tria Mitral Valve- India
Lead Sponsor:
Foldax, Inc
Conditions:
Mitral Valve Disease
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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-ran...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06191718
Start Date
March 1 2023
End Date
December 1 2024
Last Update
January 5 2024
Active Locations (10)
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1
GCS Medical College
Ahmedabad, Gujarat, India, 380025
2
Epic Hospital
Ahmedabad, Gujarat, India, 380060
3
KEM Hospital
Mumbai, Maharashtra, India, 400012
4
Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, India, 400016