CTRI/2017/08/009372进行中（未招募）4 期
Prospective REgistry to Study Clinical OutcomeEs of Repair of Mitral ValvEs in South Asia
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products ( Profile 3DTM and CG Future annuloplasty systems) in the approved intended use up to 12 months from the day of procedure.
研究概览
简要总结
Objective "o"
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
排除标准
- •Contraindications as per IFU: a.
- •Heavily calcified valves b.
- •Valvular retraction with severely reduced mobility c.
- •Active bacterial endocarditis
- •Aortic valve replacement as concomitant procedure
- •Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints.
结局指标
主要结局
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products ( Profile 3DTM and CG Future annuloplasty systems) in the approved intended use up to 12 months from the day of procedure.
时间窗: 12 months post procedure
次要结局
- Characterize the demographics of the patients undergoing mitral valve repair using annuloplasty systems in South Asia, and assess the functional and procedural outcomes of the procedure.(Discharge, 3-6 months)
研究者
研究点 (10)
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