NCT07123766尚未招募不适用
A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve
Suzhou Hearthill Medical Technology Co.,LTD0 个研究点目标入组 50 人开始时间: 2025年11月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Rate of Clinical Outcomes Events
研究概览
简要总结
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
详细描述
The PoliaValve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single-arm, open label, non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 50 patients. 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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is 45 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 1 year and is willing to comply with specified follow-up evaluations for the clinical trial
- •Diagnosed with severe symptomatic aortic valve stenosis and/or regurgitation
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 or aortic root replacement
- •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 end-stage 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 (AMI) 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
- •Currently has uncontrolled infection
- •Currently diagnosed as uncontrolled diabetes mellitus (Random BLS > 300 mg/dl)
研究组 & 干预措施
Experimental group(PoliaValve)
Experimental
Patients receiving the PoliaValve (Aortic) from HearrHill Medical
干预措施: PoliaValve (Aortic) (Device)
结局指标
主要结局
Rate of Clinical Outcomes Events
时间窗: 12 months following patient enrollment completion
The rate of adverse events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature: a) thromboembolism, b) valve thrombosis, c) major paravalvular leak, d) major hemorrhage, e) endocarditis, f) all-caused death, g) valve related death, h) valve related reoperation, i) valve explant, j) hemorrhage, k) all-cause reoperation
次要结局
- Effective Orifice Area (EOA)(12 months following patient enrollment completion)
- Mean Pressure Gradient(MPG)(12 months following patient enrollment completion)
- New York Heart Association(NYHA) Improvement Assessment(12 months following patient enrollment completion)
- Rate of Stroke(12 months following patient enrollment completion)
- Rate of Transient Ischemic Attack(TIA)(12 months following patient enrollment completion)
- Intensive Care Unit(ICU) Duration of Stay(30 days post procedure)
- Ventilation Time(30 days post procedure)
- Rate of New Onset Atrial Fibrillation(12 months post procedure)
- Length of Stay in Hospital(30 days post procedure)
- Readmission(30 days post procedure)
- Hemolysis screen(12 months post procedure)
研究者
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