Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Launched by ERASMUS MEDICAL CENTER · Apr 12, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two types of heart valves, the SAPIEN-3/Ultra and the EVOLUT R/Pro, to see which one works better for patients who need a new valve due to problems with an old surgical valve. The trial is specifically looking at patients aged 65 and older who have a failing bioprosthetic valve. To participate, patients must be eligible for a procedure called transcatheter aortic valve implantation (TAVI), which allows doctors to replace the valve without major surgery.

Participants in the trial can expect to receive one of the two valve types and will be monitored for 30 days after the procedure to assess how well the valve is working. The main goals are to ensure that the valve is placed correctly and functions properly without significant complications. Additionally, the trial will track participants for a year to check for any serious issues, like stroke or hospital readmission. This study is important because it aims to find the best treatment option for older patients with heart valve disease, potentially improving their quality of life and health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 65 years
• • Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
• • Written informed consent
• Exclusion Criteria:
• • Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro
• • Multi-valve defects requiring intervention
• • Clinically unstable and/or inotropic/vasopressor /mechanical support.
• • Known mural thrombus in the left ventricle
• • Presence of a mechanical aortic valve
• • History of recent (within 1 month) stroke or TIA