Skip to content

Cerebral Microembolism in Cardiology

Cerebral Microembolism in Interventional Cardiology Procedures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03802760
Acronym
ZEMEK
Enrollment
50
Registered
2019-01-14
Start date
2018-10-24
Completion date
2022-11-06
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Embolism

Brief summary

During different interventional cardiology procedures we aim to identify cerebral microemboli load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We will measure cerebral microemboli in different interventional phases, e.g. during valve deployment, rapid pacing, post-implantation.

Interventions

DEVICETranscranial Doppler (TCD) ultrasound measurement

Non-invasive measurement of cerebral embolic load and blood flow using TCD

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)

Exclusion criteria

* Allergy to ultrasound gel or materials contained in the TCD probe * Missing temporal bone window

Design outcomes

Primary

MeasureTime frameDescription
Quality of cerebral microemboli (solid vs. gaseous)intraoperative phase, expected to be approx. 4 hoursThe quality of cerebral microemboli is measured by Doppler ultrasonography which automatically detects and analyses the Doppler signal coming from the middle cerebral artery. According to the strength of signal reflection, the signal will be qualified as solid or gaseous.

Secondary

MeasureTime frameDescription
Quantity of cerebral microemboli loadintraoperative phase, expected to be approx. 4 hoursThe quantity of cerebral microemboli is measured by Doppler ultrasonography which automatically register the counts of solid and gaseous emboli.
Cerebral hemispheric differences (left vs. right)intraoperative phase, expected to be approx. 4 hours

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026