Actively Recruiting

Age: 18Years +
All Genders
ID07112391

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

Led by Nantes University Hospital · Updated on 2025-09-16

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nantes University Hospital

Lead Sponsor

F

Fédération Française de Cardiologie

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the function of the right ventricle in patients with severe valvular heart disease (VHD). The study focuses on measuring right ventricular to pulmonary artery (RV-PA) coupling, an important aspect of heart function, using invasive conductance catheters, which are considered the gold standard for assessing ventricular physiology. The goal is to compare these invasive measurements with non-invasive imaging methods to find reliable ways to assess RV-PA coupling in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease. Participants with severe VHD will undergo non-invasive right ventricular volumetric assessments using MRI, CT, and 3D echocardiography. Within 72 hours, they will have an invasive assessment of RV-PA coupling during routine right heart catheterization (RHC), either before surgery or during a transcatheter valvular intervention. Echocardiographic images will also be taken during RHC to compare with the invasive data, aiming to validate non-invasive imaging parameters like TAPSE/PASP ratio and RV strain. During the study, participants will have imaging and invasive assessments to gather data on RV function. Researchers will analyze the correlation between invasive measurements and non-invasive echocardiographic parameters collected during RHC. The study will monitor the participants through these procedures, with the primary outcome being the correlation of imaging results with the invasive gold standard. The total participation time includes the imaging assessments and the catheterization within a short timeframe.

CONDITIONS

Brief Title

Pressure-Volume Loop Assessment in Valvular Heart Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older
  • Patients with severe structural heart disease meeting at least one of the following: moderate-to-severe or severe secondary mitral regurgitation, severe tricuspid regurgitation, or significant pulmonary valve stenosis or regurgitation
Not Eligible

You will not qualify if you...

  • Patients under legal guardianship or protection
  • Pregnant or breastfeeding women
  • Vulnerable individuals such as persons deprived of liberty or adults under legal protection
  • Contraindications to right heart catheterization including known proximal venous occlusion of the superior or inferior vena cava, presence of a mobile mass in the right heart chambers, or significant tricuspid stenosis

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Within 3 days

Participants undergo non-invasive imaging assessments of right ventricular function and invasive hemodynamic measurements during routine right heart catheterization to evaluate RV-PA coupling.

1 to 2 visits including imaging and invasive catheterization

Long-term Monitoring

Duration - Up to study completion

Participants are observed following diagnostic procedures to support future prognostic and therapeutic investigations.

Trial Site Locations

Total: 1 location

1

CHU of NANTES

Nantes, Loire Atlantique, France, 44000

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Research Team

R

Robin LE RUZ, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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