Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation (NIMO-TAVI)

University of Basel

Status: Completed

Conditions: Aortic Valve Disease

Treatments: Device: HemoSphere ClearSight Module

Study type: Interventional

Funder types: Other

Identifiers

NCT05840757

Basel

Details and patient eligibility

About

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.

Full 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..

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Hemodynamic Monitoring

Other group

Description:

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.

Treatment:

Device: HemoSphere ClearSight Module