Clinical Research Directory

Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves

Sponsor: Ivan Zeljkovic

Summary

This study will compare the amount of cerebral microembolization during transcatheter aortic valve implantation (TAVI) between two commonly used types of transcatheter aortic valves: balloon-expandable valves and self-expanding valves. Cerebral microembolization refers to small particles or material that may travel to the brain during the procedure. These signals can be detected using transcranial Doppler ultrasound, a non-invasive method for monitoring blood flow in the brain. Although clinically apparent stroke after TAVI is relatively uncommon, small silent brain lesions may occur, and their mechanisms are not fully understood. Adult patients with severe symptomatic aortic valve stenosis who are scheduled for TAVI will be included. Participants will be randomly assigned to receive either a balloon-expandable or a self-expanding valve, both of which are established and routinely used treatment options. Transcranial Doppler monitoring will be performed before, during, and after the procedure to record the number of microembolic signals. The study will also record neurological events and procedural characteristics, such as procedure duration and the need for balloon dilatation. The aim of the study is to determine whether the type of valve is associated with a different burden of cerebral microembolization during TAVI. The results may help improve understanding of procedural factors related to cerebral embolization and may support future strategies for reducing neurological risk in patients undergoing TAVI.

Official title: Cerebral Microembolization During Transcatheter Aortic Valve Implantation: A Randomized Study Comparing Balloon-expandable and Self-expanding Valves

Key Details

Conditions

Interventions

Locations (2)