RecruitingNCT07112391

Pressure-Volume Loop Assessment in Valvular Heart Disease

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


Sponsor

Nantes University Hospital

Enrollment

70 participants

Start Date

Sep 4, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a specialized heart monitoring technique called pressure-volume loop analysis (a way to measure how the heart chambers fill and pump with each beat) to better understand heart function in people with severe valve disease. This information helps doctors make better decisions about treatment, including surgery or catheter-based procedures. **You may be eligible if...** - You are 18 years or older - You have severe structural heart disease, specifically one of: moderate-to-severe or severe mitral valve regurgitation (leaking mitral valve) with heart failure, at least severe tricuspid valve regurgitation (leaking tricuspid valve), or significant pulmonary valve disease (narrowing and/or leaking) **You may NOT be eligible if...** - You are under legal guardianship or protection - You are pregnant or breastfeeding - You have conditions that make right heart catheterization unsafe, such as blockage of the main veins, mobile clots in the right heart, or severe tricuspid valve narrowing (stenosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERObservational Invasive Hemodynamic Assessment

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.


Locations(1)

CHU of NANTES

Nantes, Loire Atlantique, France

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NCT07112391


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