Mitral Regurgitation Clinical Trial
Official title:
Clinical Investigation for the Foldax Tria Mitral Valve- India
Verified date | December 2023 |
Source | Foldax, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Epic Hospital | Ahmedabad | Gujarat |
India | GCS Medical College | Ahmedabad | Gujarat |
India | Fortis Hospital | Delhi | |
India | Indo-US Hospital | Hyderabad | Telangana |
India | SMS Hospital | Jaipur | Rajasthan |
India | NRS Medical College and Hospital | Kolkata | West Bengal |
India | Hinduja Hospital and Medical Research Centre | Mumbai | Maharashtra |
India | KEM Hospital | Mumbai | Maharashtra |
India | Six Sigma | Nashik | Maharashtra |
India | B.J. Medical College | Pune | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Foldax, Inc |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Safety Endpoints | Serious Adverse Event (SAE) rates for any valve related events. Results are compared descriptively to event rates reported in the literature. | 12 months after last patient enrollment | |
Primary | Primary Effectiveness Endpoint- Change in Hemodynamic Performance | 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. | 12 months after last patient enrollment | |
Primary | Clinical Effectiveness Endpoint- Change in New York Heart Association Assessment | 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. | 12 months after last patient enrollment | |
Secondary | Number of Participants with Stroke | Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam | 1 year following patient enrollment | |
Secondary | Number of Participants with Structural Valve Deterioration (SVD) | Assessment of patient experiencing SVD as verified by imaging, procedure, or physical exam | 1 year following patient enrollment | |
Secondary | Number of Participants with Transient Ischemic Attack | Assessment of patient having a TIA as verified by imaging and or physical exam | 1 year following patient enrollment | |
Secondary | ICU Duration of Stay | 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. | 30 Days post patient enrollment | |
Secondary | Ventilation Time | Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes | 30 Days post patient enrollment | |
Secondary | Post Procedure length of stay | 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. | 30 days post patient enrollment | |
Secondary | Kansas City Cardiomyopathy Questionnaire | Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status. | 12 months post patient enrollment | |
Secondary | Six Minute Walk Test | Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes | 12 months post patient enrollment |
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