Aortic Valve Disease
Conditions
Keywords
Transcatheter aortic valve implantation, hemodynamic parameter
Brief summary
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management. 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.
Detailed description
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management. 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..
Interventions
DEVICEHemoSphere 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.
Sponsors
University of Basel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult patients (\>18 years old) with severe aortic stenosis undergoing elective TAVI.
Exclusion criteria
* Emergency indication for TAVI * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic blood pressure | During aortic valve implantation which generally takes about 40mins | diastolic blood pressure (dBP in mmHg) |
| Systolic blood pressure | During aortic valve implantation which generally takes about 40mins | systolic blood pressure (sBP in mmHg) |
| Cardiac Output | During aortic valve implantation which generally takes about 40mins | Cardiac Output (CO in L/min) |
| Cardiac Index | During aortic valve implantation which generally takes about 40mins | Cardiac Index (CI in L/min/m2) |
Countries
Switzerland
Outcome results
None listed