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Completed

NCT Number: NCT05840757

Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cardiac Output

    Time frame: During aortic valve implantation which generally takes about 40mins

    Cardiac Output (CO in L/min)

  2. Cardiac Index

    Time frame: During aortic valve implantation which generally takes about 40mins

    Cardiac Index (CI in L/min/m2)

  3. Systolic blood pressure

    Time frame: During aortic valve implantation which generally takes about 40mins

    systolic blood pressure (sBP in mmHg)

  4. Diastolic blood pressure

    Time frame: During aortic valve implantation which generally takes about 40mins

    diastolic blood pressure (dBP in mmHg)

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Registry information

Official study title

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

Acronym: NIMO-TAVI

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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