Pressure-Volume Loop Assessment in Valvular Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥ 18 years old);
Heart failure with moderate-to-severe or severe secondary mitral regurgitation
At least severe tricuspid regurgitation
Significant pulmonary valve stenosis and/or regurgitation
Disqualifiers
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);
Known proximal venous occlusion of the superior or inferior vena cava territory
Trial population
The study population will include patients referred to Nantes University Hospital for the treatment of significant VHD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational Invasive Hemodynamic Assessment
Other interventionCollection 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Severe valvular heart disease1 intervention
Trial outcomes
Primary outcomes
1
Correlation with non-invasive echocardiographic parameters
Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.
Time frame
During right heart catheterization (Day 1)Sponsors and contacts
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Nantes University Hospital
Lead sponsor
Fédération Française de Cardiologie
Collaborator
Source ClinicalTrials.gov