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Pressure-Volume Loop Assessment in Valvular Heart Disease

Recruitingn/aAges 18 Years - anyAllNantes University Hospital
NCT07112391 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Observational Invasive Hemodynamic Assessment
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Where

1 site
CHU of NANTES
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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