Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Correlation with non-invasive echocardiographic parameters
研究概览
简要总结
The VHD PV loop study intends to assess invasive right ventricular to pulmonary artery (RV-PA) coupling in patients with valvular heart disease (VHD). Invasive RV-PA coupling is measured by using conductance catheters, the gold standard assessment for ventricular physiology. Several non-invasive parameters have been reported as surrogates for this complex physiological entity, but none of them has been tested against the gold-standard in this population. Based on this, our main objective is to assess the correlation of imaging derived RV-PA coupling in comparison to the invasive measurement.
详细描述
This study aims to improve the assessment of right ventricular (RV) function in patients with valvular heart disease (VHD), by validating non-invasive imaging parameters of right ventricular to pulmonary artery (RV-PA) coupling against invasive measurements using conductance catheters-the gold standard for evaluating RV hemodynamics.
Currently available non-invasive tools do not always provide reliable evaluation of RV-PA coupling. This study seeks to identify accurate imaging surrogates to support clinical decision-making, particularly in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease.
By correlating non-invasive indices-such as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) and RV strain-with invasive data, the study may enhance diagnostic strategies, improve patient care, and support future prognostic and therapeutic investigations. Data may also contribute to post hoc analyses in existing registries and help refine our understanding of RV adaptation in structural heart disease.
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
- •Adult patients (≥ 18 years old);
- •Patients with severe structural heart disease (meeting at least one of the following three criteria):
- •Heart failure with moderate-to-severe or severe secondary mitral regurgitation
- •At least severe tricuspid regurgitation
- •Significant pulmonary valve stenosis and/or regurgitation
排除标准
- •Patients under legal guardianship or protection (e.g., guardianship, trusteeship, or any other legal protection measure);
- •Pregnant or breastfeeding women;
- •Vulnerable individuals (e.g., persons deprived of liberty, adults under legal protection);
- •Contraindication to right heart catheterization, including:
- •Known proximal venous occlusion of the superior or inferior vena cava territory
- •Presence of a mobile mass in the right heart chambers
- •Significant tricuspid stenosis
结局指标
主要结局
Correlation with non-invasive echocardiographic parameters
时间窗: During right heart catheterization (Day 1)
Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.
次要结局
未报告次要终点