Pressure-Volume Loop Assessment in Valvular Heart Disease

Recruiting now

Conditions studied: Heart Failure, Structural Heart Disease, Interventional Cardiology

In brief

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.

Key facts

Study ID

NCT07112391

Run by

Nantes University Hospital

People needed

70

Starts

2025-09-04

Expected to finish

2027-09-04

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• CHU of NANTES — Nantes, Loire Atlantique, France (enrolling)

Full record on ClinicalTrials.gov

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