Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Aortic valve regurgitation
研究概览
简要总结
Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications.
There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract.
The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Adult patients;
- •Bicuspid aortic valve;
- •Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020;
- •Untreated aortic valve disease of no more than moderate degree (<2+) at the time of ascending aorta surgery.
排除标准
- •Emergency/urgency procedures;
- •Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery;
- •Tricuspid aortic valve tricuspid;
- •Absence of aortic valve disease;
- •Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.
结局指标
主要结局
Aortic valve regurgitation
时间窗: Through study completion, a minimum of 6 months
次要结局
未报告次要终点
研究者
Michele De Bonis
Chief of Cardiac Surgery of the Advanced and Research Therapies
Ospedale San Raffaele