An Open Label, Investigator Initiated Study, to establish the Safety and Performance Outcome of Surgical Aortic Valve with Wet Tissue in Patients with Severe Aortic Stenosis via Surgical Method

Onecrea Medical India Pvt Ltd.1 个研究点分布在 1 个国家目标入组 3 人开始时间: 2024年11月29日最近更新: 2024年11月6日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 3
试验地点: 1
主要终点: The primary study endpoints are safety and performance endpoints:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is to evaluate safety and performance outcomes following treatment with the study device in subjects with malfunctioning aortic valve, as determined by the heart team who require replacement of their native aortic valve due to severe, native aortic valve stenosis (AS). The surgical valve is designed to be implanted in the calcified native aortic annulus of patients with severe aortic stenosis via surgical method.

The surgical valve consists of 4 components:The stent, bovine pericardial leaflets, PET fabric, and suture. The stent is polyester-covered stent and is injection-moulded using polyetheretherketone (PEEK) material. The stent material is impregnated with barium sulphate to allow for radiographic visualization. The leaflets are cut from bovine pericardial tissue that has been cross-linked using glutaraldehyde and anti-calcification treated to mitigate calcification. The leaflets are assembled into the stent, and then all components are securely sutured together. A sewing ring is formed using the PET fabric on the inflow side of the stent cover to allow the user to suture the Surgical valve in the supra-annular position. To demonstrate the safety and performance Outcome of Surgical Aortic Valve with Wet Tissue in Patients with Severe Aortic Stenosis via Surgical Method.

The study comprises of following visits: -

Visit 1: Screening Visit/Baseline visit.

Visit 2: Day of Surgery

Visit 3: Day of Discharge (Discharge as per the patient condition and investigator discretion)

Visit 4: 1-month post-surgery (Â± 3 days)

Visit 5: 3-month post-surgery (Â± 3 days)

Visit 6: 6 months post-surgery (Â± 7 days)

Visit 7: 12 months post-surgery (Â± 7 days)

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 55.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•Patient must be 55 years or older.
•Patient provides written informed consent and agrees to all follow-ups at clinical investigational sites that are participating in the OneCrea SAVR study.
•Patient life expectancy is at least 1 year.
•Diagnosed with aortic disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, 2D echocardiography, and CBC).
•The physician considers the patient a candidate for a bioprosthetic heart valve.
•STS scores should be less than 4 percent (Low Risk)
•Patient has moderate to severe Aortic stenosis or Aortic regurgitation, or combination of aortic lesion (stenosis and regurgitation).
•Patient anatomy is eligible for SAVR treatment with the investigational device per the Indications in the Instructions for Use.
•The patient is in a geographic location that will enable the patient to return to the study site for follow-up examinations.
•The patient or patientâ€™s legal representative signs an informed consent form prior to enrolment.

排除标准

•Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled aortic valve replacement surgery.
•Has renal insufficiency as determined by creatinine (S-Cr) level greater than or equal to 2.5 gram per decilitre or end-stage renal disease requiring chronic dialysis at screening visit.
•Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or TIA within 6 months (180 days) prior to planned valve surgery.
•Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery.
•Diagnosed with abnormal calcium metabolism and hyperparathyroidism.
•Exhibits left ventricular ejection fraction less than or equal to 30 percent as validated by diagnostic procedure prior to planned valve surgery.
•Echocardiographic evidence of an intra-cardiac mass, 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 less than 3.5 x 10Â³ per microlitre), acute anemia (Hgb less than 10.0 gram per decilitre or 6 millimoles per litre) or thrombocytopenia (platelet count less than 50 x 10Â³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy.
•Has prior organ transplant or is currently an organ transplant candidate.
•The patient is currently participating in a study of an investigational drug or device.
•Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study.
•Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material.
•Currently unable to give voluntary informed consent.
•A known hypersensitivity or contraindication to bivalirudin, polyetheretherketone (PEEK) material, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.
•The patient has a malignancy or other disease with a poor 2-year prognosis which may interfere with the ability to conduct follow-up (i.e. metastatic cancer).
•The patient is a known alcohol or drug abuser.
•The patient is currently participating in the study of an unapproved drug or device.