Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption
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
- 15
- 试验地点
- 6
- 主要终点
- Primary Safety Endpoints
研究概览
简要总结
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.
详细描述
The Foldax Polymer Mitral Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 15 patients. These patients will be followed up to 5 years 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
- 否
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:
- •Moderate to severe mitral valve stenosis,
- •Moderate to severe mitral valve regurgitation, or
- •Moderate to severe mixed mitral stenosis/regurgitation
- •Able to withstand short term anticoagulation
- •Willing and able to comply with protocol requirements
排除标准
- •Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
- •Requires emergency surgery
- •Requires other planned surgery within 12 months of valve replacement
- •Active endocarditis or active myocarditis
- •Acute preoperative neurological deficit defined as neurological deficit < 3 months prior to enrollment
- •Non-cardiac illness resulting in a 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 or hepatic failure
- •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 prisoners or mentally ill
- •Patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating
- •Has a positive test result for COVID-19 virus (baseline or preoperative)
- •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 Safety Endpoints
时间窗: 12 months following patient enrollment completion
Adverse Event (AE) rates for valve related early and late complications : thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, endocarditis, structural valve deterioration, nonstructural valve dysfunction, valve related hemolysis, all cause death, valve related reoperation, valve explant, and valve related death. Results are visually compared to event rates reported in the literature.
Primary Effectiveness Endpoints- Change in Hemodynamic Performance
时间窗: 12 months following patient enrollment completion
Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement.
Clinical Effectiveness: Change in New York Heart Association Assessment
时间窗: 12 months following patient enrollment completion
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
- ICU Duration of Stay(30 days post patient enrollment)
- Number of Participants with Stroke(5 years following patient enrollment)
- Number of Participants with Transient Ischemic Attack(5 years following patient enrollment)
- Number of Participants with Migration of the TRIA valve(5 years following patient enrollment)
- New Onset Atrial Fibrillation(12 months post patient enrollment)
- Post Procedure length of stay(30 days post patient enrollment)
- Ventilation Time(30 days post patient enrollment)
- Readmission within 30 days of discharge(30 days post patient discharge date)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(12 months post patient enrollment)
- Six Minute Walk Test(12 months post patient enrollment)