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临床试验/NCT04053192
NCT04053192已完成不适用

Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2018年6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
166
试验地点
1
主要终点
Post-Procedure Hemodynamic Changes

研究概览

简要总结

The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.

详细描述

The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used for dilatation of serve aortic stenosis. With this minimally invasive intervention an increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of transvalvular gradients and ultimately a symptom relief should be achieved. The required effect is temporary and a definitive treatment should be aspired in suitable patients. Therefor Transcatheter Aortic Valve Replacement (TAVR) is available.

Following the guidelines of the European Society of Cardiology for the management of valvular heart disease from 2017, the aortic stenosis can be divided into different subtypes by using haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a poorer prognosis when treated curative as well as when treated palliative medicamentous, because these patients show coronary and myocardial restrictions more frequently in addition to the valvular disease.

The aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit equally from these interventions.

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
50 Years 至 97 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Severe Aortic Stenosos who underwent BAV

排除标准

  • insufficient echocardiographic parameters before BAV

结局指标

主要结局

Post-Procedure Hemodynamic Changes

时间窗: 24 - 72 h after procedure

dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR

All-cause Mortality

时间窗: 1-Year post BAV

次要结局

  • Number of patients with stroke(30 days after intervention)
  • Number of patients with myocardial infarction(30 days after intervention)
  • Number of patients with bleeding complications(30 days after intervention)
  • Number of patients with acute kidney injury(30 days after intervention)
  • Number of patients with vascular complications(30 days after intervention)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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