Cerebral Microembolism in Cardiology

Completed

• Conditions: Cerebral Embolism
• Interventions: Device: Transcranial Doppler (TCD) ultrasound measurement

• Registration Number: NCT03802760
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-22
• Study Start: 2018-10-24
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Primary Completion: 2022-02-24
• Status Verified: 2022-11
• Study Completion: 2022-11-06
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MitraClip patients	Transcranial Doppler (TCD) ultrasound measurement	Patients undergoing MitraClip implantation
TricuspidalClip	Transcranial Doppler (TCD) ultrasound measurement	Patients undergoing TricuspidalClip implantation
TAVI patients	Transcranial Doppler (TCD) ultrasound measurement	Patients undergoing transfemoral TAVI

Primary Outcome Measures

Name	Time	Method
Quality of cerebral microemboli (solid vs. gaseous)	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 Outcome Measures

Name	Time	Method
Quantity of cerebral microemboli load	intraoperative phase, expected to be approx. 4 hours	The 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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine; 🇨🇭 Bern, Switzerland