Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation

NCT05840757 | Completed

• 1 other identifier: Basel
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Keywords

Transcatheter aortic valve implantation; hemodynamic parameter

Outcome Measures

Primary Outcomes (4)

• Cardiac Output

  Cardiac Output (CO in L/min)

  During aortic valve implantation which generally takes about 40mins

• Cardiac Index

  Cardiac Index (CI in L/min/m2)

  During aortic valve implantation which generally takes about 40mins

• Systolic blood pressure

  systolic blood pressure (sBP in mmHg)

  During aortic valve implantation which generally takes about 40mins

• Diastolic blood pressure

  diastolic blood pressure (dBP in mmHg)

  During aortic valve implantation which generally takes about 40mins

Study Arms (1)

Hemodynamic Monitoring

OTHER

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

Interventions

HemoSphere ClearSight Module DEVICE

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.

Hemodynamic Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years old) with severe aortic stenosis undergoing elective TAVI.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Basel: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Structural Cardiology

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 3, 2023
• Study Start: March 31, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)