Clinical Investigation for the Foldax Tria Mitral Valve- India

Foldax

Status

Active, not recruiting

Conditions

Mitral Valve Disease

Mitral Valve Insufficiency

Mitral Regurgitation

Mitral Stenosis

Treatments

Device: Mitral Valve Replacement

Study type

Interventional

Funder types

Industry

Identifiers

NCT06191718

CP-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.