Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation

Aortic Valve Disease Clinical Trial

— NIMO-TAVI  

Official title:

Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation - A Single-center, Prospective, Interventional Study With the ClearSight® Finger Cuff

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840757
• Other study ID #: Basel
• Status: Completed
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output	Cardiac Output (CO in L/min)	During aortic valve implantation which generally takes about 40mins
Primary	Cardiac Index	Cardiac Index (CI in L/min/m2)	During aortic valve implantation which generally takes about 40mins
Primary	Systolic blood pressure	systolic blood pressure (sBP in mmHg)	During aortic valve implantation which generally takes about 40mins
Primary	Diastolic blood pressure	diastolic blood pressure (dBP in mmHg)	During aortic valve implantation which generally takes about 40mins