Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Launched by INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC, UNIVERSITY LAVAL · Jul 12, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well a heart valve replacement works after a specific procedure called valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). The study compares two methods of measuring how well the new valve is performing: one using an ultrasound technique called Doppler-echocardiography and the other using a more direct method called catheterization. Researchers want to find out if measuring with ultrasound gives a different result compared to catheterization, as some studies suggest it might show higher pressure than what is actually there. This could mean that the failure rates of these heart valves might be lower than previously thought.

To participate in this trial, patients need to be between the ages of 65 and 74 and must have a specific type of heart valve problem called severe aortic stenosis or regurgitation. They should also be scheduled for a valve-in-valve replacement with a particular valve type. However, patients with certain types of heart valves or those at high risk for complications may not be eligible. If you join this study, you’ll help researchers understand the best ways to assess how well heart valves are working after replacement, which could lead to better care for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team
• • Surgical stented bioprosthetic valve (label size ≤25 mm)
• • TAVR with the SAPIEN 3 Ultra valve
• Exclusion Criteria:
• • Stentless or sutureless surgical valves
• • Trifecta bioprosthesis
• • Hancock II bioprosthesis
• • High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \<4 mm or based on the criterion of the heart team responsible for the procedure).
• • Impossibility to obtain written informed consent