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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU of NANTES
RECRUITING
Nantes
Contact Information
Primary
Robin LE RUZ, MD, PhD
robin.leruz@chu-nantes.fr
02. 53.48.28.36
Time Frame
Start Date: 2025-09-04
Estimated Completion Date: 2027-09-04
Participants
Target number of participants: 70
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital
Collaborators: Fédération Française de Cardiologie

This content was sourced from clinicaltrials.gov