Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement

Karolinska University Hospital1 个研究点分布在 1 个国家目标入组 1,000 人2017年1月25日

适应症Aortic Valve Stenosis

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Aortic Valve Stenosis
发起方: Karolinska University Hospital
入组人数: 1000
试验地点: 1
主要终点: Number of patients with major vascular complications
最后更新: 5年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.

注册库

clinicaltrials.gov

开始日期

2017年1月25日

结束日期

2021年1月31日

最后更新

5年前

研究类型

Observational

性别

All

研究者

发起方

Karolinska University Hospital

责任方

Principal Investigator

主要研究者

Magnus Dalén

Associate professor

Karolinska University Hospital

入排标准

入选标准

•Patients undergoing transfemoral TAVI at the Karolinska University Hospital

排除标准

•Patients undergoing TAVI with access other than transfemoral
•Use of closure device other than MANTA

结局指标

主要结局

Number of patients with major vascular complications

时间窗: 6 week follow up

Major vascular access site complications according to the VARC-2 definitions

次要结局

Number of patients with minor vascular complications(6 week follow up)
Number of patients with vascular closure device failure(6 week follow up)
Number of patients with life-threatening, disabling or major bleeding(6 week follow up)