Optimized Expansion of the Implanted Transcatheter Aortic Valve

Launched by OLE DE BACKER · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to improve a heart valve replacement procedure called transcatheter aortic valve implantation (TAVI), which is used to treat severe narrowing of the aortic valve (aortic stenosis). The researchers want to see if using a careful technique to prepare and expand the valve during the procedure can reduce a common problem called leaflet thickening, where the thin flaps of the valve become thicker and might affect how well the valve works. They will check this by using a special type of heart scan called a CT scan three months after the procedure.

People who might be eligible for this study are adults with severe symptoms from aortic stenosis who have been recommended to have TAVI, and who can follow the study instructions. However, patients who need blood thinners for other reasons, have serious kidney problems, or cannot have the CT scan because of allergy or other issues won’t be able to join. Participants will undergo the heart valve procedure using either the new optimized method or the standard method, and they will have a CT scan three months later to see how well the valve is working. This study is not yet recruiting, but it aims to find better ways to improve outcomes for patients having TAVI.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Severe symptomatic aortic stenosis patients with an indication for TAVI
• • Ability to understand and to comply with the study protocol
• Exclusion Criteria:
• • Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve)
• • Creatinine clearance \<15 mL/min (CKD-EPI formula) or on renal replacement therapy
• • Iodine contrast allergy or other condition that prohibits cardiac CT imaging