Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Transmitral pressure gradient
研究概览
简要总结
Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
详细描述
There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy.
Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertrophic obstructive cardiomyopathy
- •Left ventricle outflow tract gradient > 50 mm Hg at rest
- •Systolic anterior motion mediated mitral regurgitation
排除标准
- •Intrinsic valvular heart disease
- •Coronary artery disease
- •Aortic disease
结局指标
主要结局
Transmitral pressure gradient
时间窗: 30-days
Transmitral pressure gradient after the procedures assessed by echocardiography
次要结局
- Residual left ventricle outflow tract gradient(intraoperative measuerment)
- Early mortality(30 days)
- Repeat bypass(30 day)