Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- Cardiovascular mortality
研究概览
简要总结
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
详细描述
Hydra-IT is a multicenter observational study conducted across different centres in Italy. The primary objective of the study is to evaluate the safety and efficacy of transcatheter aortic valve implantation and clinical outcome in patients treated with Hydra device. Secondary objective is to evaluate the long term (up to 5 years) effectiveness and the quality of treatment using Hydra device. Patients with severe stenosis symptomatic of the native aortic valve or bioprosthesis in a degenerated aortic position will be included in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team
- •Ability to understand and provide informed consent for inclusion in the study
排除标准
- •Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.
- •Refusal by the patient to participate in the study
- •High probability of non-adherence to required follow-ups
结局指标
主要结局
Cardiovascular mortality
时间窗: 30 days
次要结局
- Myocardial infarction(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- New permanent pacemaker implantation (PPM)(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Effective Orifice Area (EOA)(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- All-cause mortality(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- All stroke(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Disabling stroke(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Life-threatening or disabling bleeding(30 days)
- Major vascular complications(30 days)
- Acute kidney injury (Stage 2 or 3)(30 days)
- Mean aortic valve gradient(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- New York Heart Association (NYHA) functional classification(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Paravalvular Leak (PVL)(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)