Heart Failure, Interventional Cardiology, Structural Heart Disease
Conditions
Keywords
Chronic heart failure, Structural heart disease, Interventional cardiology, Multimodality imaging
Brief summary
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.
Detailed description
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.
Interventions
OTHERObservational Invasive Hemodynamic Assessment
Collection and analysis of invasive hemodynamic data obtained through routine cardiac catheterization performed as part of standard care. No intervention is mandated by the study protocol.
Sponsors
Fédération Française de Cardiologie
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation with non-invasive echocardiographic parameters | During right heart catheterization (Day 1) | Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio. |
Countries
France
Contacts
Primary ContactRobin LE RUZ, MD, PhD
Outcome results
None listed