Clinical trial NCT06191718: Clinical Investigation for the Foldax Tria Mitral Valve- India
Official title: Clinical Investigation for the Foldax Tria Mitral Valve- India
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Disease
Mitral Regurgitation
Mitral Stenosis
Mitral Valve Insufficiency
Lead sponsor: Foldax, Inc
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety Endpoints
timeFrame: 12 months after last patient enrollment
measure: Primary Effectiveness Endpoint- Change in Hemodynamic Performance
timeFrame: 12 months after last patient enrollment
measure: Clinical Effectiveness Endpoint- Change in New York Heart Association Assessment
timeFrame: 12 months after last patient enrollment
Secondary outcomes:
measure: Number of Participants with Stroke
timeFrame: 1 year following patient enrollment
measure: Number of Participants with Structural Valve Deterioration (SVD)
timeFrame: 1 year following patient enrollment
measure: Number of Participants with Transient Ischemic Attack
timeFrame: 1 year following patient enrollment
measure: ICU Duration of Stay
timeFrame: 30 Days post patient enrollment
measure: Ventilation Time
timeFrame: 30 Days post patient enrollment
measure: Post Procedure length of stay
timeFrame: 30 days post patient enrollment
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 12 months post patient enrollment
measure: Six Minute Walk Test
timeFrame: 12 months post patient enrollment
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: GCS Medical College
state: Gujarat
city: Ahmedabad
country: India
facility: Epic Hospital
state: Gujarat
city: Mumbai
country: India
facility: KEM Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Hinduja Hospital and Medical Research Centre
state: Maharashtra
city: Nashik
country: India
facility: Six Sigma
state: Maharashtra
city: Pune
country: India
facility: B.J. Medical College
state: Maharashtra
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Hyderabad
country: India
facility: Indo-US Hospital
state: Telangana
city: Kolkata
country: India
facility: NRS Medical College and Hospital
state: West Bengal
city: Delhi
country: India
facility: Fortis Hospital
Study officials:
References: