NCT04339452进行中（未招募）不适用
Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: a Single Center Prospective Observational Study
Lucian Archambault Durham III1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intraoperative hemodynamic stability
研究概览
简要总结
The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Ejection fraction ≤ 35%
- •Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon) or Left main disease
- •Adequate Distal target caliber (as determined by the PI or operating surgeon)
排除标准
- •Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:
- •Patients with structural heart disease requiring cardiopulmonary bypass
- •Patients with cardiogenic shock who require a period of short-term mechanical circulatory support
- •Patients with mechanical aortic valve
- •Patients with previous median sternotomy
- •Patients with evidence of non-viability on preoperative cardiac MRI or CT scan
- •Insufficient conduit
- •BMI over 50
- •Suspected or known pregnancy
结局指标
主要结局
Intraoperative hemodynamic stability
时间窗: Intraoperative
Intraoperative hemodynamic stability, defined as mean arterial pressure (MAP), cardiac index (CI), central venous pressure (CVP), and cerebral perfusion as measured by NIRS maintained within normal ranges for the entire operative time except potentially for short periods not exceeding 10 minutes in total time.
次要结局
未报告次要终点
研究者
Lucian Archambault Durham III
Lucian Durham, MD, PhD
Medical College of Wisconsin
研究点 (1)
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