CTRI/2024/04/064961尚未招募4 期
A prospective, multi-centre, single-arm, investigator-initiated study to evaluate the safety and performance of Dafodil™ PerICardial BioprosThesis in patients undergoing native/prosthetic Aortic or miTral valvE replacement. - DICTATE
Meril Diagnostics private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patients whose valvular disease is sufficiently advanced to warrant
- •replacement of their natural/prosthetic aortic or mitral valve with Dafodil
- •pericardial bioprosthesis or its subsequent advanced version.
- •2. Patients who are willing to undergo all protocol specific study procedures
- •and follow-up requirements.
- •3. Patient or his/her Legally Acceptable Representative (LAR) has been
- •informed about the nature of the registry and informed consent for study
- •participation has been obtained from the patient or LAR, as per applicable
- •local requirements.
排除标准
- •1. Patients who are not willing to provide informed consent form, or whose
- •legal heirs object to their participation in the study
- •2. Any condition, which, in Investigator’s or heart team’s opinion would
- •preclude safe participation of patients in the study
研究者
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