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临床试验/NCT03179969
NCT03179969已完成不适用

Interventional Therapy of Paravalvular Post-surgical or Post-interventional Valve Replacement Leaks With Plug Devices: The German Plug - Registry

Stiftung Institut fuer Herzinfarktforschung1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2017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
49
试验地点
1
主要终点
mortality risk

研究概览

简要总结

In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk

详细描述

In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk. For a number of years, the catheter-based closure of the defect has been increasingly used by means of the implantation of plug-devices as a new treatment method for patients with a high surgical risk. The existing data on the operation method and safety of the method already used at some centers are promising. In order to demonstrate the clinical routine of patients with an interventional occlusion of a PVL in a timely manner, the Stiftung IHF Ludwigshafen will publish a multicentric register entitled "Deutsches Plug Register" The goal is, among other things, the documentation of patient characteristics, indications, and complications of treated patients.The German Heart Foundation promotes the setting up of the plug register.

In this time, 200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.

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

入选标准

  • heart valve replacement
  • Valve Replacement Leaks
  • Plug Device

排除标准

  • no written consent

结局指标

主要结局

mortality risk

时间窗: five years

observation of the mortality risk

次要结局

未报告次要终点

研究者

发起方
Stiftung Institut fuer Herzinfarktforschung
申办方类型
Other
责任方
Sponsor

研究点 (1)

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