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

Starting soon · Not applicable

Conditions studied: Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT07614100

Run by

Ivan Zeljkovic

People needed

80

Starts

2026-06-01

Expected to finish

2027-02-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Severe symptomatic aortic valve stenosis
• Clinical indication for transcatheter aortic valve implantation
• Feasibility of transcranial Doppler ultrasound monitoring
• Signed written informed consent

You may not qualify if…

• Recent stroke or transient ischemic attack
• Significant cerebrovascular disease preventing reliable transcranial Doppler -assessment
• Previous aortic valve implantation
• Active endocarditis
• Pregnancy or breastfeeding

Where it is running

• Sisters of Charity Hospital Zagreb — Zagreb, Croatia
• UH Dubrava — Zagreb, Croatia

Full record on ClinicalTrials.gov

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