跳至主要内容
临床试验/NCT05726799
NCT05726799已完成不适用

Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月5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
60
试验地点
1
主要终点
Mortality

研究概览

简要总结

In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. In these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. These patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. Since 2015, our Institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium.

The aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy.

The primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy.

Secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for PM implantation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients (≥ 18 years)
  • meeting the clinical and echocardiographic criteria that made them candidates for isolated myectomy or in combination with other surgical procedures:
  • LV outflow tract instantaneous peak gradient >50mmHg at rest or during stimulation
  • interventricular septum >16mm,
  • NYHA functional class III-IV, despite maximal medical therapy
  • operated in San Raffaele Hospital with classic or cryo myectomy between 2015 and 2018.

排除标准

  • extent of myectomy not reported in the operative report;
  • left ventricular outflow tract gradient not reported in pre- or postoperative echocardiography.

结局指标

主要结局

Mortality

时间窗: Up to 4 years

次要结局

未报告次要终点

研究者

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

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

研究点 (1)

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