SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
研究概览
简要总结
The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to include patients in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to five years.
详细描述
The present registry aims to assess the safety and efficacy of TAVI with CE approved devices at Swiss cardiovascular centers. The Swiss Working group of Interventional Cardiology and Acute Coronary Syndrome decided to establish a nationwide registry in collaboration with the Swiss Society of Cardiac Surgery in order to assess the procedural and clinical outcome of TAVI patients. This prospective registry will help to identify candidates for TAVI, will report on peri-procedural outcome and on long-term efficacy of the devices. Last but not least it is a tool to increase quality of treatment of this high-risk patient population.
Methods
This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Native aortic valve stenosis
- •Native aortic valve regurgitation
- •Degenerated aortic bioprosthesis requiring treatment
- •Exclusion Criteria
- •Patients refuses informed consent to participate in the registry
- •Contraindication for TAVI
- •High probability of non-adherence to the follow up - requirements
排除标准
- 未提供
结局指标
主要结局
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
时间窗: 1 year
Composed by: * death * stroke * aortic valve re-intervention * structural valve deterioration * myocardial Infarction
次要结局
- combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)(10 years , 15 years)
- combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)(30days)