Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The change in the FFR value before and after TAVI
研究概览
简要总结
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
详细描述
The POTUS study is a prospective, investigator-initiated, single-arm observational study with invasive measurements that will consist of two cohorts. The first cohort consists of 120 patients with intermediate coronary artery disease who undergo a transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis ('TAVI cohort'). The second cohort consists of 30 patients with intermediate coronary artery disease who undergo transcatheter mitral valve repair (TMVr) for functional/degenerative mitral regurgitation ('TMVr cohort'). Both cohorts will undergo a battery of coronary physiological tests both before and after the valvular intervention. Additionally, in the case that the fractional flow reserve (FFR) over a coronary lesion is significant (i.e. FFR ≤ 0.80) during the post valvular intervention measurements, additional percutaneous coronary intervention (PCI) will take place during the same procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team.
- •b) TMVr cohort: severe functional/degenerative mitral regurgitation for which TMVr is scheduled after discussion in the Heart Team.
- •At least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel ≥ 2.5 mm
- •Elective procedure
- •Written informed consent
排除标准
- •TAVI cohort: height coronary ostia < 10 mm
- •Severe chronic kidney disease, defined as estimated glomerular filtration rate < 30 ml/min.
- •Contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine.
- •Degenerated surgical or transcatheter aortic valve bioprosthesis.
- •Vessels that have collaterals to a chronic total occlusion or that are supplied by an arterial or venous bypass graft will not be interrogated in this study.
结局指标
主要结局
The change in the FFR value before and after TAVI
时间窗: Directly before and after the TAVI procedure (1 hour)
The impact of TAVI on FFR
The change in the FFR value before and after TMVr
时间窗: Directly before and after the TMVr procedure (1 hour)
The impact of TMVr on FFR
次要结局
- The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
- The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)(Directly before and after the TAVI/TMVr procedure (1 hour))
研究者
Nicolas van Mieghem
Prof. Dr. Nicolas M. Van Mieghem
Erasmus Medical Center