Cerebral Microembolism in Cardiology

NCT ID: NCT03802760

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-24

Study Completion Date

2022-11-06

Brief Summary

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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

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Conditions

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Cerebral Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TAVI patients

Patients undergoing transfemoral TAVI

Transcranial Doppler (TCD) ultrasound measurement

Intervention Type DEVICE

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

MitraClip patients

Patients undergoing MitraClip implantation

Transcranial Doppler (TCD) ultrasound measurement

Intervention Type DEVICE

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

TricuspidalClip

Patients undergoing TricuspidalClip implantation

Transcranial Doppler (TCD) ultrasound measurement

Intervention Type DEVICE

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

Interventions

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Transcranial Doppler (TCD) ultrasound measurement

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Gabor Erdös

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-01066

Identifier Type: -

Identifier Source: org_study_id

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