Clinical Investigation for the Foldax Tria Mitral Valve- India
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Foldax, Inc
- 入组人数
- 70
- 试验地点
- 20
- 主要终点
- Primary Effectiveness Endpoint- Change in Hemodynamic Performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Primary Effectiveness Endpoint- Change in Hemodynamic Performance
时间窗: 12 months after last patient enrollment
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.
Primary Safety Endpoints
时间窗: 12 months after last patient enrollment
Serious Adverse Event (SAE) rates for any valve related events. Results are compared descriptively to event rates reported in the literature.
Clinical Effectiveness Endpoint- Change in New York Heart Association Assessment
时间窗: 12 months after last patient enrollment
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.
次要结局
- Number of Participants with Structural Valve Deterioration (SVD)(1 year following patient enrollment)
- ICU Duration of Stay(30 Days post patient enrollment)
- Six Minute Walk Test(12 months post patient enrollment)
- Number of Participants with Transient Ischemic Attack(1 year following patient enrollment)
- Ventilation Time(30 Days post patient enrollment)
- Post Procedure length of stay(30 days post patient enrollment)
- Number of Participants with Stroke(1 year following patient enrollment)
- Kansas City Cardiomyopathy Questionnaire(12 months post patient enrollment)