NCT01991431已完成不适用
Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve
Institut für Pharmakologie und Präventive Medizin19 个研究点 分布在 9 个国家目标入组 303 人开始时间: 2013年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 19
- 主要终点
- Overall mortality
研究概览
简要总结
This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.
详细描述
The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing transaortic transcatheter procedure with the commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ System.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intended transaortic (Tao) TAVI using Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System
- •Compliance with the indications according to the Instructions for Use
- •Written informed consent
排除标准
- •Presence of contraindications as to the Instructions for Use
- •TAo with concomitant procedure (e.g. Tao + CABG)
- •Participation in the SOURCE XT registry
结局指标
主要结局
Overall mortality
时间窗: 30 days
to determine Overall mortality within 30 days after TAVI
次要结局
- Number of Patients with adverse Events in Relation to Baseline Parameters(30 days after TAVI)
- complication rates(30 days after TAVI)
- TAVI-related in-Hospital and 30 d mortality(30 days after TAVI)
研究者
研究点 (19)
Loading locations...
相似试验
招募中
不适用
Transpacific TAVR RegistryHeart Valve DiseasesAortic Valve InsufficiencyNCT03826264Duk-Woo Park, MD10,000
招募中
不适用
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve RegurgitationAortic Valve RegurgitationNCT06381271Xijing Hospital500
进行中（未招募）
不适用
Global Registry for Endovascular Aortic Treatment (GREAT)Multiple PathologiesNCT01658787W.L.Gore & Associates4,600
已完成
不适用
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life PracticeAortic StenosisNCT02698956Edwards Lifesciences2,000
已完成
不适用
Everyday Practice With Transcatheter Aortic Valve ImplantationAortic Valve StenosisNCT02289339LMU Klinikum2,370