Early Feasibility Study for the Foldax Tria Aortic Heart Valve
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
- 40
- 试验地点
- 10
- 主要终点
- Primary Safety Endpoints: Surgical Valve Events Rate Assessment
研究概览
简要总结
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic 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 Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic 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 40 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
- •Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
- •Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial
- •Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations
排除标准
- •Requires multiple valve replacement / repair
- •Requires emergency surgery
- •Has had prior valve surgery
- •Requires a surgical procedure outside of the cardiac area
- •Requires a cardiac procedure other than a CABG or root enlargement
- •Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device
- •Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
- •Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit
- •Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery
- •Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery
- •Has life expectancy to less than 12 months
- •Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
- •Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
- •Echocardiographic left ventricular ejection fraction <25%
- •Echocardiographic evidence of an intra-cardiac thrombus or vegetation
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
- •Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy
- •Has prior organ transplant or is currently an organ transplant candidate
- •Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
- •Pregnant, lactating or planning to become pregnant during the duration of participation in trial
- •Currently incarcerated or unable to give voluntary informed consent
- •Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
- •Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
- •Tests positive for an active infection with SARS-CoV-2 (COVID-19)
结局指标
主要结局
Primary Safety Endpoints: Surgical Valve Events Rate Assessment
时间窗: 12 months following patient enrollment completion
The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death
Primary Effectiveness Endpoint: New York Heart Association Improvement 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.
Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments
时间窗: 12 months following patient enrollment completion
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis
Primary Effectiveness Endpoint: Hemodynamic Performance Assessment
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.
次要结局
- Secondary Endpoint: Length of Stay in Hospital(30 days post procedure)
- Secondary Endpoint: ICU Duration of Stay(30 days post procedure)
- Secondary Endpoint: New Onset Atrial Fibrillation(12 Months post procedure)
- Secondary Endpoint: Ventilation Time(30 Days post procedure)
- Secondary Endpoint: Readmission(30 days post discharge)
- Secondary Endpoints: Stroke(5 years following patient enrollment)
- Secondary Endpoint: Transient Ischemic Attack(5 Years following patient enrollment)
- Secondary Endpoint: Hemolysis screen(12 months post procedure)
- Secondary Endpoint: Change in Quality of Life (QOL)(12 months post procedure)