Pressure-Volume Loop Assessment in Valvular Heart Disease (VHD-PV-loop)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Structural Heart Disease; Heart Failure; Interventional Cardiology

Treatments: Other: Observational Invasive Hemodynamic Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07112391

RC25_0116

Details and patient eligibility

About

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.

Full description

This study aims to improve the assessment of right ventricular (RV) function in patients with valvular heart disease (VHD), by validating non-invasive imaging parameters of right ventricular to pulmonary artery (RV-PA) coupling against invasive measurements using conductance catheters-the gold standard for evaluating RV hemodynamics.

Currently available non-invasive tools do not always provide reliable evaluation of RV-PA coupling. This study seeks to identify accurate imaging surrogates to support clinical decision-making, particularly in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease.

By correlating non-invasive indices-such as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) and RV strain-with invasive data, the study may enhance diagnostic strategies, improve patient care, and support future prognostic and therapeutic investigations. Data may also contribute to post hoc analyses in existing registries and help refine our understanding of RV adaptation in structural heart disease.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Severe valvular heart disease

Description:

Patients with severe Valvular Heart Disease (VHD) will undergo a RV volumetric assessment (MRI, CT, 3D-echocardiography) followed within 72h by an invasive assessment of RV-PA coupling using conductance catheters, either as a preoperative evaluation or at the time of transcatheter valvular intervention. Echocardiographic images will be acquired during right heart catheterization (RHC) in order to be compared to the gold-standard.

Treatment:

Other: Observational Invasive Hemodynamic Assessment