A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- primary composite safety endpoint
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
详细描述
This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.
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
- •Age ≥ 18 years
- •Patients who are clinically indicated for aortic valve replacement
- •Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent
排除标准
- •Previous surgical or/and transcatheter cardiac valve replacement at any site
- •Previous open-heart surgical valve repair at any site
- •Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
- •Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
- •Untreated clinically significant coronary artery diseases requiring revascularization
- •Acute myocardial infarct within the previous 30 days
- •Severe right heart dysfunction
- •Active infection requiring antibiotic therapy including infective endocarditis
- •Hypertrophic obstructive cardiomyopathy (HOCM)
- •Severe symptomatic carotid artery stenosis
- •Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
- •Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
- •Hematologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Hematooncology specialists
- •Severe chronic lung disease
- •Previous organ transplant or currently an organ transplant candidate Anatomical
- •LVEF < 20%
- •Left ventricular end diastolic diameter (LVEDD) >70mm
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
- •Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
- •Urgent, emergency or salvage surgeries
- •Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
- •Life expectancy ≤ 1 year due to non-cardiac reasons
- •Planned relevant concomitant procedure within 30 days post index procedure
- •Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
- •Pregnant, breastfeeding or intend to become pregnant within 1 year
- •Currently incarcerated or unable to give voluntary informed consent
结局指标
主要结局
primary composite safety endpoint
时间窗: 1 year
composite safety endpoint at 1 year, including: valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, major paravalvular leak (defined as moderate or greater paravalvular leak or any paravalvular leak requiring intervention), valve thrombosis, endocarditis
次要结局
- secondary composite safety endpoint(2 through 5 Years)
- Occurrence of each of the following adverse events(baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter)