Pressure-Volume Loop Assessment in Valvular Heart Disease
NCT ID: NCT07112391
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2025-09-04
2027-09-04
Brief Summary
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Detailed Description
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Currently available non-invasive tools do not always provide reliable evaluation of RV-PA coupling. This study seeks to identify accurate imaging surrogates to support clinical decision-making, particularly in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease.
By correlating non-invasive indices-such as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) and RV strain-with invasive data, the study may enhance diagnostic strategies, improve patient care, and support future prognostic and therapeutic investigations. Data may also contribute to post hoc analyses in existing registries and help refine our understanding of RV adaptation in structural heart disease.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Observational 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.
Interventions
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Observational 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fédération Française de Cardiologie
OTHER
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Robin LE RUZ, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital of Nantes
Locations
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CHU of NANTES
Nantes, Loire Atlantique, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC25_0116
Identifier Type: -
Identifier Source: org_study_id
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