NCT05991271尚未招募不适用
Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- The rate of deaths at the one-year follow-up visit post procedure
研究概览
简要总结
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
详细描述
This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.
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 with the symptoms of severe aortic stenosis
- •Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography
- •Patients deemed for cardiac intervention by a heart team
- •Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
- •Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements
排除标准
- •A subject meeting any of the following criteria shall be excluded:
- •Co-morbidities
- •Previous mechanical or biological aortic valve replacement
- •Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
- •Acute myocardial infact within 30 days prior to index procedure
- •Untreated clinical significant coronary artery disease requiring revascularization
- •Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)
- •Sever symptomatic carotid artery stenosis
- •Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
- •Chronic kidney disease (eGFR<30 mL/min/1.73m2)
- •Haemotologic 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 Haematooncology specialists
- •Severe right heart dysfunction Anatomical
- •LVEF < 20%
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •Inappropriate anatomy for femoral introduction and delivery of study device
- •Native aortic valve geometry and size unfavorable for study device anchoring General
- •Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
- •Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement
- •Life expectancy ≤ 1 year due to noncardiac reasons
- •Active infection requiring antibiotic therapy including infective endocarditis
- •Planned relevant concomitant procedure within 30 days post index procedure
- •Pregnant, breastfeeding or intend to become pregnant within 1 year
结局指标
主要结局
The rate of deaths at the one-year follow-up visit post procedure
时间窗: 1 Years
All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
Acceptable Hemodynamic Performance at 30 days
时间窗: 30 Days
Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as: * Mean gradient \< 20mmHg * Less than moderate aortic regurgitation (perivalvular and transvalvular)
次要结局
- The rate of device success is defined as the following(Up to 1 week)
- The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:(Up to 1 week)
- The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT(30-Days)
- New York Heart Association (NYHA) classification during follow-up(5 Years)
- Technical success is defined as the following(During the Procedure)
- The rate of freedom from mild or greater PVL by echocardiogram during follow-up(5 Years)
- Occurrence of the following adverse events echocardiogram during follow-up(5 Years)
- The rate of freedom from severe coronary overlap assessed by post-implant angiogram(immediately after the procedure)
研究者
相似试验
尚未招募
不适用
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic ValveAortic Valve DiseaseCardiovascular DiseasesNCT05941455Jilin Venus Haoyue Medtech Limited155
Unknown
3 期
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary RegurgitationRight Ventricular Outflow Tract StenosisNCT02071654Venus MedTech (HangZhou) Inc.44
招募中
不适用
VenusP-Valve Pivotal Study (PROTEUS STUDY)Pulmonary RegurgitationNCT06010563Venus MedTech (HangZhou) Inc.60
已完成
不适用
The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral SystemVertebral Compression FractureNCT03580434Hyprevention9
终止
不适用
Clinical Evaluation of the TRVD™ System in ADHFCongestive Heart FailureAcute Heart FailureHeart Failure, CongestiveNCT03621436Magenta Medical Ltd.13