NCT Number: NCT07614100
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Sisters of Charity Hospital Zagreb, Zagreb, Croatia
This is a prospective, randomized, parallel-group clinical study designed to compare cerebral microembolization during transcatheter aortic valve implantation between balloon-expandable and self-expanding transcatheter aortic valves.
The study will be conducted at University Hospital Dubrava and Sisters of Charity Hospital (Zagreb) with an expected duration of one year. Adult patients aged 18 years or older with severe symptomatic aortic valve stenosis and an indication for transcatheter aortic valve implantation will be considered for participation.
Eligible participants will be randomized using a computer-generated randomization sequence into one of two study groups according to the type of implanted valve: a balloon-expandable valve or a self-expanding valve. Both valve types represent standard, widely accepted therapeutic options in contemporary clinical practice. The study does not introduce a new or insufficiently tested technology, and participation will not change the standard course of treatment or expose patients to additional risk beyond that normally associated with the procedure.
All participants will undergo a standard TAVI procedure with periprocedural anticoagulation according to current clinical guidelines. Cerebral microembolization will be assessed using transcranial Doppler ultrasound. Monitoring will be performed immediately before the procedure, during the procedure, and after the procedure. The presence and number of microembolic signals will be recorded, including analysis across specific procedural phases such as instrumentation, valvuloplasty, valve implantation, and the post-implantation period.
The primary outcome will be the difference in the change in the number of microembolic signals between the balloon-expandable and self-expanding valve groups. Secondary outcomes will include the change in microembolic signal burden within each group, the distribution of microembolic signals across procedural phases, the occurrence of new microembolic signals after the procedure, the incidence of clinical neurological events, and the association between procedural characteristics and microembolic signal burden.
Collected data will include demographic and clinical characteristics, such as age, sex, and comorbidities, as well as procedural data including procedure duration, vascular access route, need for predilatation or postdilatation, and procedural complications. Data will be analyzed using appropriate statistical methods for between-group and within-group comparisons, depending on data distribution.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Before, during, and immediately after the TAVI procedure
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.
Time frame: Before, during, and immediately after the TAVI procedure
Change in the number of cerebral microembolic signals detected by transcranial Doppler ultrasound before, during, and after TAVI will be assessed separately within each valve group.
Time frame: During the TAVI procedure and immediately after valve implantation
The number of cerebral microembolic signals will be analyzed according to procedural phase, including instrumentation, valvuloplasty, valve implantation, and the post-implantation period.
Time frame: Immediately after the TAVI procedure
he occurrence and number of new cerebral microembolic signals detected after completion of the TAVI procedure will be recorded and compared between the study groups.
Time frame: Periprocedural
The association between procedural characteristics, including procedure duration, vascular access route, predilatation, postdilatation, and procedural complications, and the number of cerebral microembolic signals will be assessed.
Time frame: Periprocedural
The correlation between procedure duration, measured in minutes, and cerebral microembolic signal burden, measured as the number of cerebral microembolic signals detected by transcranial Doppler monitoring, will be assessed.
Contact information is provided by the study sponsor or research team.
Mihovil Santini, MD
CONTACT
Zeljković, PhD,MD
CONTACT
Ivan Zeljkovic
Other
Cerebral Microembolization During Transcatheter Aortic Valve Implantation: A Randomized Study Comparing Balloon-expandable and Self-expanding Valves
Acronym: MICROTAVI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07539259
Aortic Stenosis, Aortic Valve Disease
View Trial DetailsNCT07690748
Aortic Stenosis, Aortic Valve Disease
View Trial DetailsNCT07623083
Aortic Stenosis, Aortic Valve Disease
View Trial DetailsNCT06818006
Aortic Stenosis, Aortic Valve Disease
Edmonton, Alberta, Canada
View Trial Details