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

NCT07614100 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Balloon-expandable transcatheter aortic valve

A balloon-expandable transcatheter aortic valve will be implanted during a standard transcatheter aortic valve implantation procedure in participants randomized to this intervention arm. This valve type is an established and routinely used treatment option for severe symptomatic aortic valve stenosis. Cerebral microembolization will be monitored using transcranial Doppler ultrasound before, during, and after the procedure.

DEVICE

Self-expanding transcatheter aortic valve

A self-expanding transcatheter aortic valve will be implanted during a standard transcatheter aortic valve implantation procedure in participants randomized to this intervention arm. This valve type is an established and routinely used treatment option for severe symptomatic aortic valve stenosis. Cerebral microembolization will be monitored using transcranial Doppler ultrasound before, during, and after the procedure.

Sponsors & Collaborators

  • University Hospital Dubrava

    collaborator OTHER

  • Sisters of Mercy University Hospital

    collaborator OTHER

  • Ivan Zeljkovic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-01-30
Completion
2027-02-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614100 on ClinicalTrials.gov