Clinical trial NCT05840757: Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation
Official title: Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation - A Single-center, Prospective, Interventional Study With the ClearSight® Finger Cuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: Transcatheter aortic valve implantation
hemodynamic parameter
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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..

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Output
timeFrame: During aortic valve implantation which generally takes about 40mins
measure: Cardiac Index
timeFrame: During aortic valve implantation which generally takes about 40mins
measure: Systolic blood pressure
timeFrame: During aortic valve implantation which generally takes about 40mins
measure: Diastolic blood pressure
timeFrame: During aortic valve implantation which generally takes about 40mins
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
References: