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

NCT07614100 | Not Yet Recruiting

• 1 other identifier: 2026/0423-10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Microembolism

Outcome Measures

Primary Outcomes (1)

• Change in Number of Cerebral Microembolic Signals During TAVI

  he primary outcome is the difference between study groups in the change in the number of cerebral microembolic signals detected by transcranial Doppler ultrasound before, during, and after transcatheter aortic valve implantation. The comparison will be made between participants receiving balloon-expandable valves and those receiving self-expanding valves.

  Before, during, and immediately after the TAVI procedure

Secondary Outcomes (5)

• Number of Cerebral Microembolic Signals Within Each Study Group

  Before, during, and immediately after the TAVI procedure

• Distribution of Cerebral Microembolic Signals by Procedural Phase

  During the TAVI procedure and immediately after valve implantation

• Occurrence of New Cerebral Microembolic Signals After TAVI

  Immediately after the TAVI procedure

• Incidence of Clinical Neurological Events

  Periprocedural

• Correlation Between Procedure Duration and Cerebral Microembolic Signal Burden

  Periprocedural

Study Arms (2)

Balloon-Expandable Valve

ACTIVE COMPARATOR

Participants in this arm will undergo transcatheter aortic valve implantation using a balloon-expandable transcatheter aortic valve. This valve type is a standard and routinely used treatment option for patients with severe symptomatic aortic valve stenosis. Cerebral microembolization will be assessed by transcranial Doppler ultrasound before, during, and after the procedure.

Device: Balloon-expandable transcatheter aortic valve

Self-Expanding Valve

ACTIVE COMPARATOR

articipants in this arm will undergo transcatheter aortic valve implantation using a self-expanding transcatheter aortic valve. This valve type is a standard and routinely used treatment option for patients with severe symptomatic aortic valve stenosis. Cerebral microembolization will be assessed by transcranial Doppler ultrasound before, during, and after the procedure.

Device: Self-expanding transcatheter aortic valve

Interventions

Self-expanding transcatheter aortic valve DEVICE

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.

Self-Expanding Valve

Balloon-expandable transcatheter aortic valve DEVICE

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.

Balloon-Expandable Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ivan Zeljkovic: lead
• University Hospital Dubrava: collaborator
• Sisters of Mercy University Hospital: collaborator

Study Sites (2)

Sisters of Charity Hospital Zagreb

Zagreb, 10000, Croatia

Location

UH Dubrava

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Zeljković, PhD,MD

CONTACT

+385917823289; ivanzeljkov@gmail.com

Mihovil Santini, MD

CONTACT

+385958101778; 023miho@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Head of Diagnostic and Therapeutic Department for Cardiac Electrostimulation and Electrophysiology

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (2)