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临床试验/NCT01811537
NCT01811537Unknown1 期

Phase II Study of Using a New Device (Neochordameter) in Making Artificial Chordae for Mitral Valve Repair

Tehran University of Medical Sciences0 个研究点目标入组 20 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
主要终点
Mortality

研究概览

简要总结

Mitral prolapse is a common cardiac disease whose patients are at higher risk for serious complications. Mitral valve (MV) repair offers several important advantages compared with valve replacement and it achieves excellent midterm and long-term results. Two major problems of using pre-measured expanded polytetrafluoroethylene(ePTFE) neochordae (the loop technique) are deciding the length of the neochordae and tying the knot at the intended length. Therefore, a great need still exists to find new method to simplify and precise the length of neochordae. 20 patients with mitral valve prolapse who undergo mitral valve repair using neochorda will be recruited in this study. Trans thoracic echocardiography (TTE) will be done preoperatively for all patients. Two, three, and four chamber view of each patient will be pre-operatively recorded. The device will be set with extracted measurements. Artificial corda loops are made using CV-4 ePTFE sutures. After artificial chordae replacement, the ring annuloplasty will be done. Follow up: A leakage test after attaching the 1st loop; Post operative trans esophageal echocardiography (TEE) and determining the severity of mitral regurgitation [Wall motion Score Index (WMSI), Mitral Annulus Area (MAA), LVEF, End Systolic Volume (ESV), End Diastolic Volume (EDV), Iso-Volemic Relaxation Time (IVRT), (IVRT/(QE-QE^') ,Chamber Relaxation velocity)/(Myocard relaxation velocity(E/E^' ), HR]; TEE 3 months after discharge; Cross clamp time; Intubation period in ICU.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with Mitral valve prolapse who undergo mitral valve repair using neochorda

排除标准

  • 未提供

结局指标

主要结局

Mortality

时间窗: Early (within 30 days after surgery), Late (After 12 months)

次要结局

  • Mitral Valve prolapse measurement after using neochordae(Intra-operation, 3, 6, and 12 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alireza Ghavidel

Associat Professor of Cardiac Surgery

Tehran University of Medical Sciences

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