Post-Approval Study for the MOSAIC® Bioprostheses: A Long Term Follow Up Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- long-term safety of the valve
研究概览
简要总结
A Single Center Non-Interventional Post-Market Release, Long Term Follow Up study of patients who underwent Isolated Aortic Valve Replacement or Isolated Mitral Valve Replacement with a Medtronic Mosaic Bioprosthesis. The purpose of this study is to evaluate the long term safety, efficacy and clinical performance of the Mosaic Bioprostheses.
详细描述
Objectives:
The primary objectives of this study are to evaluate the long-term safety, efficacy and clinical performance.
Study Design:
This is a prospective, single center, non-interventional, non-randomized, post-market release clinical study
Sample Size and Study Duration:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who were enrolled and implanted with a Mosaic bioprosthesis in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic PMA study, will be invited to participate in this long-term follow- up study.
- •Patients who are able to provide informed consent
排除标准
- •Patients who are not from the Albertinen-Krankenhaus (Hamburg, Germany) and who did not participate in the Mosaic PMA study are ineligible for this study.
- •Patients refusing or not able to provide informed consent.
- •Patients not willing and unable to comply with the CIP-requirements
结局指标
主要结局
long-term safety of the valve
时间窗: Long term follow up: 10 years and longer
The long-term safety of the valve will be assessed by the rate of valve related complications.
The long-term durability of the valve will be assessed by measuring hemodynamic performance of the valve Long-term performance of the valve
时间窗: Long term follow up: 10 years and longer
The long-term performance of the valve will be assessed by measuring hemodynamic performance of the valve by echo
Long-term efficacy of the valve
时间窗: Long term follow up: 10 years and longer
The long-term efficacy of the valve will be assessed by evaluating the New York Heart Association Functional Classification (NYHA)
次要结局
未报告次要终点