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临床试验/NCT05308173
NCT05308173已完成不适用

Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Low-risk Elective Patients. Data From Multicenter Registry.

Nicolaus Copernicus University0 个研究点目标入组 2,393 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,393
主要终点
all-cause death

研究概览

简要总结

Multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (TAVI) or surgical aortic valve replacement between 2015 and 2019. In TAVI group only transfemoral access was considered.

详细描述

A retrospective analysis of the Multicenter Aortic Valve Registry patients operated between 2015 and 2019 in the three departments of cardiac surgery in Poland: the Medical University of Silesia in Katowice, Medical University in Gdańsk, and Poznań, University of Medical Science. Baseline clinical, procedural, and outcome data at follow-up were entered into prespecified electronic case report forms. Follow-up status was validated by personal contact or access to Polish National Health Fund. Patients with planned concomitant intervention on coronary arteries (by bypass grafting or percutaneous intervention), other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded too. In TAVI group only femoral access was considered. For SAVR any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Elective procedure
  • Aortic valve replacement with means of TAVI or SAVR

排除标准

  • Concomitant procedures

结局指标

主要结局

all-cause death

时间窗: up to 6 years

death resulting from cardiovascular and non-cardiovascular causes

次要结局

未报告次要终点

研究者

发起方
Nicolaus Copernicus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariusz Kowalewski

PhD, M.D.

Nicolaus Copernicus University

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