Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation
NCT ID: NCT05840757
Last Updated: 2024-05-14
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2023-03-31
2023-12-31
Brief Summary
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The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.
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Detailed Description
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The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.
The ClearSight monitoring system works non-invasively by utilizing an inflatable finger cuff which adjusts automatically to measure the arterial blood pressure which enables the calculation of parameters such as cardiac output or index. Multiple studies have demonstrated the reliability and feasibility of continuous non-invasive monitoring, in different settings, however it was never performed in patients undergoing TAVI.
The ClearSight monitoring system will be directly compared to invasive measurements of hemodynamic parameters during the procedure. In addition, information regarding baseline hemodynamics and its changes during/after procedure may give important information on peri- and post-procedural management and short-term outcomes and discharge planning. A tool, providing this information non-invasively with the same accuracy might result in a major improvement in daily practice..
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Hemodynamic Monitoring
Simultaneous measurement of hemodynamic parameters such as Cardiac output, cardiac index and blood pressure with invasive right heart catheterization and non-invasive application of the Clearsight Finger Cuff.
HemoSphere ClearSight Module
The Clear Sight system consists of a finger cuff connected to a monitor It will be applied to the patients finger before and removed after the TAVI procedure.
Interventions
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HemoSphere ClearSight Module
The Clear Sight system consists of a finger cuff connected to a monitor It will be applied to the patients finger before and removed after the TAVI procedure.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe tricuspid regurgitation
* Severe mitral stenosis or severe regurgitation
* Invasive right heart catheterization impossible
* Dependency on right ventricle pacing immediately after TAVI implantation
* Vulnerable subjects
* Known or suspected non-compliance, drug or alcohol abuse
* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation affecting this study
* Previous enrolment into the current investigation
18 Years
ALL
No
Sponsors
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University of Basel
OTHER
Responsible Party
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Thomas Nestelberger
Head of Structural Cardiology
Locations
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University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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Basel
Identifier Type: -
Identifier Source: org_study_id
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