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临床试验/NCT04112108
NCT04112108已完成不适用

Late (up to 12 Years) Clinical and Echocardiographic Outcomes of Percutaneous Transvenous Mitral Commissurotomy in Patients With Rheumatic Mitral Stenosis: Continuing Secondary Antibiotic Prophylaxis Does Not Protect Against Late Events

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
mitral stenosis

研究概览

简要总结

In this retrospective cohort study, out of 220 patients who had undergone successful PTMC between 2006 and 2018, the clinical course of 186 patients could be successfully followed. Peri-procedural clinical and echocardiographic data were collected for these patients. Cardiac-related death, undergoing a second PTMC or mitral valve replacement (MVR) were considered adverse cardiac events in follow-up for the purpose of this study. Patients with no history of these events were contacted and asked to undergo echocardiographic imaging, in order to assess the prevalence of mitral valve restenosis, defined as mitral valve area (MVA) < 1.5 cm2 and loss of ≥50% of initial area gain

详细描述

This research was designed as single-technique (Inoue balloon), multicenter retrospective- prospective cohort study. The target group of this study consisted of 220 patients with symptomatic MS who had undergone PTMC at in 4 hospitals (Baqiyatallah, Namazi, Shahid-Faghihi and Kowsar) under the supervision of Baqiyatallah University of Medical Sciences and Shiraz University of Medical Sciences between April 2006 and January 2018. The demographic data of the patients were obtained from the medical records departments at each center.

The inclusion criteria for the participants were: 1) age more than 20 years at the time of PTMC; 2) immediate post-PTMC mitral valve area (IMVA) ≥1.5 cm2, or for lower values, at least 50% increase in pre-PTMC mitral valve area (MVA); 3) an initial cardiovascular event-free period of at least 6 months after the procedure.

The exclusion criteria consisted of: 1) more than 2+ mitral regurgitation (MR) immediately after the procedure; 2) immediate cardiovascular event during the hospital stay after the procedure; 3) more than mild aortic stenosis or sufficiency before PTMC; 4) history of previous PTMC or surgical mitral procedures.

The study design and steps were approved by the ethics committees at both Baqiyatallah and Shiraz University of Medical Sciences.

PTMC Technique All PTMC procedures were done with an Inoue balloon catheter by skilled interventional cardiologists via anterograde trans-septal approach in all patients. Right and left cardiac catheterization was performed before and during the procedure to assess hemodynamic changes. Optimal balloon size (in millimeters) was estimated with the height (cm)/10 + 10 formula. The balloon was inflated in a step-wise fashion from lower to higher volumes. After each inflation, changes in trans-mitral mean pressure gradient (TMPG) and the degree of mitral regurgitation (MR) were monitored. Based on interventionist's judgement and in order to achieve optimal results, balloon inflation could be continued up to 1-2 mm more than the estimated size. In the last stage, left ventriculography was conducted to assess the degree of final MR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
35 Years 至 52 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • each patient with mitral stenosis undergone successful PTMC

排除标准

  • patient refuse to took part
  • inability to follow patient

结局指标

主要结局

mitral stenosis

时间窗: 5.6 years

mitral valve area in echocardiographic evaluation\<1.5 cm2

次要结局

  • functional class(5.6 years)

研究者

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

Javad Kojuri

Professor

Shiraz University of Medical Sciences

研究点 (1)

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