NIMO-TAVI: Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation

• Sponsor: University of Basel (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05840757
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease	Device: HemoSphere ClearSight Module	N/A

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..

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation - A Single-center, Prospective, Interventional Study With the ClearSight® Finger Cuff
• Actual Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Cardiac Output [During aortic valve implantation which generally takes about 40mins]

   Cardiac Output (CO in L/min)

2. Cardiac Index [During aortic valve implantation which generally takes about 40mins]

   Cardiac Index (CI in L/min/m2)

3. Systolic blood pressure [During aortic valve implantation which generally takes about 40mins]

   systolic blood pressure (sBP in mmHg)

4. Diastolic blood pressure [During aortic valve implantation which generally takes about 40mins]

   diastolic blood pressure (dBP in mmHg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel	BS	Switzerland	4031

Sponsors and Collaborators

• University of Basel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Nestelberger, Head of Structural Cardiology, University of Basel
• ClinicalTrials.gov Identifier: NCT05840757
• Other Study ID Numbers: Basel
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Thomas Nestelberger, Head of Structural Cardiology, University of Basel: Transcatheter aortic valve implantation; hemodynamic parameter
• Additional relevant MeSH terms: Aortic Valve Disease

Study Results

No Results Posted as of May 3, 2023