Prospective REgistry to Study Clinical OutcomeEs of Repair of Mitral ValvEs in South Asia

Medtronic Plc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1) Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3DTM and CG Future annulopasty systems.
•2) Indications and contraindications provided in the product Instructions for Use
•3) Subject is 18 years of age or older
•4) The patient or his/her Legally Authorised Representative ( LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements.

•1. Contraindications as per IFU:
•a. Heavily calcified valves
•b. Valvular retraction with severely reduced mobility
•c. Active bacterial endocarditis
•2. Aortic valve replacement as concomitant procedure
•3. Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints

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