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Invasive Heart Pressure Study in People With Valve Disease

Compares invasive heart pumping measurements with imaging-based estimates in adults with valvular heart disease.

Plain-language title generated from the registry record
Registry title: Pressure-Volume Loop Assessment in Valvular Heart Disease

Key facts

Where
Nantes, FranceSee the site

Where in France

  • CHU of NantesNantes, FranceTaking people

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Trial details

Who runs it
Nantes University Hospital
Trial code
NCT07112391
Record updated
16 September 2025
Original description
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.Read full original descriptionShow less

Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach

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.

Inclusion: 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: 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; 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).

ClinicalTrials.gov NCT07112391