Pressure-Volume Loop Assessment in Valvular Heart Disease

NCT07112391 | Recruiting

• 1 other identifier: RC25_0116
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Structural Heart Disease; Interventional Cardiology

Keywords

Chronic heart failure; Structural heart disease; Interventional cardiology; Multimodality imaging

Outcome Measures

Primary Outcomes (1)

• Correlation with non-invasive echocardiographic parameters

  Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.

  During right heart catheterization (Day 1)

Study Arms (1)

Severe valvular heart disease

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.

Other: Observational Invasive Hemodynamic Assessment

Interventions

Observational Invasive Hemodynamic Assessment OTHER

Collection and analysis of invasive hemodynamic data obtained through routine cardiac catheterization performed as part of standard care. No intervention is mandated by the study protocol.

Also known as: Cardiac Catheterization, Hemodynamic Procedure

Severe valvular heart disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients referred to Nantes University Hospital for the treatment of significant VHD.

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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fédération Française de Cardiologie: collaborator

Study Sites (1)

CHU of NANTES

Nantes, Loire Atlantique, 44000, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Robin LE RUZ, MD, PhD

  Hospital of Nantes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin LE RUZ, MD, PhD

CONTACT

02. 53.48.28.36; robin.leruz@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 8, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): September 4, 2027
• Study Completion (Estimated): September 4, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (1)