A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Percentage of Participants With Technical Success
研究概览
简要总结
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.
The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.
详细描述
Severe symptomatic aortic valve stenosis is a progressive disease associated with significant morbidity and mortality if left untreated. Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for appropriately selected patients with severe native aortic valve disease who are considered suitable candidates for transcatheter intervention.
This clinical investigation is designed to evaluate an investigational transcatheter aortic valve replacement system developed for the treatment of severe symptomatic native aortic valve stenosis. The study will collect clinical evidence to assess the safety and performance of the investigational device in accordance with the Clinical Investigation Plan and applicable regulatory requirements.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older.
- •Symptomatic severe native calcific aortic valve stenosis.
- •Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.
- •Considered at high surgical risk for surgical aortic valve replacement.
- •Able to understand the study requirements and provide written informed consent.
- •Willing and able to comply with all study procedures and follow-up visits.
排除标准
- •Contraindication to transcatheter aortic valve replacement or the investigational procedure.
- •Active infection or endocarditis.
- •Life expectancy less than one year due to non-cardiac comorbidities.
- •Participation in another investigational study that could interfere with the objectives of this study.
- •Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.
结局指标
主要结局
Percentage of Participants With Technical Success
时间窗: At completion of the index procedure (exit from procedure room)
Technical success of the investigational transcatheter aortic valve replacement procedure as assessed according to the Clinical Investigation Plan and predefined study criteria.
Percentage of Participants With Device Success
时间窗: 30 days after the procedure
Device success following implantation of the investigational transcatheter aortic valve replacement system as assessed according to the Clinical Investigation Plan using predefined performance criteria.
Percentage of Participants Free From Early Safety Events
时间窗: 30 days after the procedure
Early safety of the investigational transcatheter aortic valve replacement system based on predefined clinical safety criteria specified in the Clinical Investigation Plan.
次要结局
- All-cause Mortality rate(Through 5 years)
- Cardiovascular Mortality Rate(Through 5 years)
- Percentage of Participants Experiencing Stroke(Through 5 years)
- Rate of Valve- or Procedure-Related Rehospitalization(Through 5 years)
- Hemodynamic Valve Performance assessed by Echocardiography(Through 5 years)
- Change From Baseline in NYHA Functional Class(Baseline through 5 years)
- Change From Baseline in Six-Minute Walk Test (6MWT) Distance(Baseline through 5 years)
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Overall Summary Score(Baseline through 5 years)
- Percentage of Permanent Pacemaker Implantation(Through 5 years)