Invasive Heart Pressure Study in People With Valve Disease
Compares invasive heart pumping measurements with imaging-based estimates in adults with valvular heart disease.
Key facts
- Who runs it
- Nantes University Hospital
- Where
- Nantes, FranceSee the site
- Trial code
- Registry title
- Pressure-Volume Loop Assessment in Valvular Heart Disease
- Status
- Recruiting
- People taking part
- 70 people, planned
- Started
- 4 Sept 2025
- Expected to end
- 4 Sept 2027
- Type of study
- Observational
- Treatments tested
- Observational Invasive Hemodynamic Assessment
- Record updated
- 16 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe heart valve disease who need a detailed pressure test of the right heart and lung blood vessels using a catheter.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Severe structural heart disease: heart failure with moderate-to-severe or severe secondary mitral regurgitation, or at least severe tricuspid regurgitation, or significant pulmonary valve stenosis and/or regurgitation.
Main reasons for not taking part
- Under legal guardianship or legal protection
- Pregnant or breastfeeding women
- Vulnerable people, for example people deprived of liberty
- A reason that rules out right heart catheterization: blocked large vein, mobile mass in the right heart, or significant tricuspid stenosis
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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)
Where in France
- CHU of NantesNantes, FranceContact: ROBIN LE RUZ, cardiologist, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- 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.
Treatment: Observational Invasive Hemodynamic Assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach
- Plain-language title
- Invasive Heart Pressure Study in People With Valve DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 16 September 2025