NCT07112391Recruiting
Pressure-Volume Loop Assessment in Valvular Heart Disease
Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Nantes University Hospital
- Diseases
- Heart failure
- NCT number
- NCT07112391
What you commit to
- Study type: Observational
- Planned participants: 70
- From Sept 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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);
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU of Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.