Pressure-Volume Loop Assessment in Valvular Heart Disease
Recruiting · NCT07112391 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nantes University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Observational Invasive Hemodynamic Assessment
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- CHU of NANTES - Nantes, Loire Atlantique, France