Measuring how the right ventricle and pulmonary artery work together in valve disease

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

This project will test whether non-invasive heart imaging can match invasive catheter measurements of right ventricular–pulmonary artery coupling in adults with significant valvular heart disease.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (other)
• Locations: 1 site (Nantes, Loire Atlantique)
• Trial ID: NCT07112391 on ClinicalTrials.gov

What this trial studies

This observational study will enroll adults with significant structural valve disease (severe secondary mitral regurgitation, at least severe tricuspid regurgitation, or significant pulmonary valve disease) at CHU Nantes. Participants will undergo invasive right-heart hemodynamic assessment using conductance catheters—the gold standard for RV physiology—alongside standard non-invasive imaging. Researchers will compare invasive RV–PA coupling measures with imaging-derived indices such as TAPSE/PASP and RV strain to quantify correlations. The goal is to identify accurate imaging surrogates that could support clinical decision-making in valvular heart disease.

Who should consider this trial

Good fit: Adults (≥18 years) with severe structural valvular disease—moderate-to-severe or severe secondary mitral regurgitation, at least severe tricuspid regurgitation, or significant pulmonary valve stenosis/regurgitation—who can safely undergo right-heart catheterization.

Not a fit: Patients who are pregnant or breastfeeding, under legal guardianship, or who have contraindications to right-heart catheterization (for example proximal venous occlusion, a mobile right-heart mass, or significant tricuspid stenosis) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, clinicians could rely on validated non-invasive imaging measures to estimate RV–PA coupling, reducing the need for invasive catheterization and improving timing and selection for valve interventions.

How similar studies have performed: Several non-invasive measures like TAPSE/PASP and RV strain have shown promise in other populations, but they have not been directly validated against conductance-catheter measurements in patients with valvular heart disease.

Eligibility criteria

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 this trial is running

Nantes, Loire Atlantique

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

Study contacts

• Principal investigator: Robin LE RUZ, MD, PhD — Hospital of Nantes
• Study coordinator: Robin LE RUZ, MD, PhD

Conditions: Heart Failure, Structural Heart Disease, Interventional Cardiology, Chronic heart failure, Structural heart disease, Interventional cardiology, Multimodality imaging