Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation

University of Basel50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Aortic Valve Disease

Interventions

HemoSphere ClearSight ModuleDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Outcomes

Primary Outcomes

Cardiac Output

Cardiac Output (CO in L/min)

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

Cardiac Index

Cardiac Index (CI in L/min/m2)

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

Systolic blood pressure

systolic blood pressure (sBP in mmHg)

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

Diastolic blood pressure

diastolic blood pressure (dBP in mmHg)

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

Data from ClinicalTrials.gov

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