A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- FFR Values Prior to Transcatheter Aortic Valve Replacement
研究概览
简要总结
Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced. The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR) and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values, and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.
详细描述
The purpose of the study is to determine whether iFR assessment gives a valid assessment of coronary hemodynamics in patients with severe aortic stenosis.
Several factors confound the interpretation of fractional flow reserve (FFR) in patients with severe aortic stenosis (AS) and intermediate severity coronary stenoses, and the widely accepted cut-off value of 0.80 may not be applicable to this patient population. Coronary flow reserve is known to be attenuated under conditions of left ventricular hypertrophy and severe AS, with one study showing improvement in coronary flow reserve after aortic valve replacement. Left ventricular hypertrophy produces fixed resistance secondary to external compression of the coronary microcirculation. This potentially results in failure to achieve maximal hyperemia with adenosine and can lead to false negative FFR results. Neurohormonal influences in aortic stenosis can further attenuate vasodilator response and potentially result in false negative FFR values. Both of these conditions result in the potential deferral of lesions which may have been hemodynamically significant in the absence of severe AS. At present, there are no studies which have demonstrated validity of FFR measurement in patients with severe AS. Here, the investigators propose a prospective study of iFR/FFR in patients with AS and indeterminate coronary lesions undergoing TAVR to understand the hemodynamic consequences of AS on iFR/FFR. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 110 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have coronary stenoses between 40-70% severity and who have severe aortic stenosis undergoing TAVR work-up.
排除标准
- •Patients with documented intraprocedural hemodynamic instability, shock, or major adverse event (myocardial infarction, aortic rupture/dissection, stroke, left ventricular perforation, cardiac arrest).
- •Contraindication to adenosine, presence of cardiogenic shock, presence of acute coronary syndrome.
结局指标
主要结局
FFR Values Prior to Transcatheter Aortic Valve Replacement
时间窗: Immediately prior to transcatheter aortic valve replacement, during the index procedure
Hemodynamic significance of a coronary stenosis by measuring FFR immediately prior to TAVR
FFR Values During the Transcatheter Aortic Valve Replacement (TAVR)
时间窗: Immediately after transcatheter aortic valve replacement, during the index procedure
Hemodynamic significance of a coronary stenosis by measuring FFR immediately after TAVR
次要结局
未报告次要终点
