Skip to main content
Clinical Trials/NCT03802760
NCT03802760
Completed
Not Applicable

Cerebral Microembolism in Interventional Cardiology Procedures

Insel Gruppe AG, University Hospital Bern1 site in 1 country50 target enrollmentOctober 24, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Embolism
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
50
Locations
1
Primary Endpoint
Quality of cerebral microemboli (solid vs. gaseous)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 24, 2018
End Date
November 6, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gabor Erdös

Principal Investigator

Insel Gruppe AG, University Hospital Bern

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of cerebral microemboli (solid vs. gaseous)

Time Frame: intraoperative phase, expected to be approx. 4 hours

The 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 Outcomes

  • Quantity of cerebral microemboli load(intraoperative phase, expected to be approx. 4 hours)
  • Cerebral hemispheric differences (left vs. right)(intraoperative phase, expected to be approx. 4 hours)

Study Sites (1)

Loading locations...

Similar Trials