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The EurValve prospective study will compare computer predictions of the outcomes of heart valve replacement surgery with the actual results obtained in normal clinical practice.
Vascular Heart Disease patients receiving normal clinical treatment, will agree to provide data to support the assessment of the EurValve computation model.
The main objective of the project is to predict the change in cardiac characteristics following valve replacement (aortic valve pressure gradient, mitral valve regurgitant fraction). It will also identify the utility of patient-specific measures of cell physiology and determine the utility of activity data in predicting outcome in valve replacement.
EurValve will develop a comprehensive Decision Support System (DSS), maximally incorporating patient-specific data to provide as tailored a recommendation as possible. Key to the DSS design is the initial definition of the matching comprehensive data set that will inform the modelling and decision engine.
This dataset must allow for information from current patient pathways (including imaging by CT and Echo, laboratory testing, and other clinical data).
It must also allow information from anticipated future pathways, in particular MR imaging. MR imaging drives the EurValve haemodynamic modelling process and is expected to enter clinical guidelines.
Computational model testing will be carried out within a prospective clinical study.
Design of the clinical study
Design of the clinical study
Enrolment
Enrolment
Aortic valve disease
Aortic valve stenosis/insufficiency N=60
Mitral valve insufficiency
N=60
Before treatment
Before treatment
Clinical routine data
ECG, lab, anthropometrics, medical history, medication
Functional cardiac assessment
Echocardiogram, MRI
Functional vascular profile
MRI
Valve segmentation
Echocardiogram/CT
Environmental data (Sheffield)
Activity monitoring
Treatment
Treatment
Valve replacement/repair according to current clinical guidelines
Proteomic information (Berlin)
Biopsy taken during procedure
Follow-up
Follow-up
Clinical routine data
ECG, lab, anthropometrics, medication
Functional cardiac assessment
Echocardiogram, MRI
Functional vascular profile
MRI
Valve segmentation
Echocardiogram/CT
Environmental data (Sheffield)
Activity monitoring
Steps
Steps
Before treatment, treatment and follow-up lead to
Step one - Validation: Comparison of modelled (predicted) vs measured outcomes
Step two - DSS integration: Comparison of virtual decision making vs current clinical decision making
The EurValve Patient Information Sheet (PDF, 540KB) contains information of what the trial will involve for those taking part.
Activity monitoring
Activity monitoring
One part of the EurValve project is for us to understand how people’s daily lives change after surgery. In order to do this we ask each patient to wear a Bristol University Sphere Wristband, and to plug-in 3 ‘Access Points’ around their home to monitor activity.
Heart rate monitoring
Heart rate monitoring
A second wristwatch, the Philips health watch continuously tracks activity, calorie burn, sleep habits, heart rate and other key metrics of the patient’s cardio condition.
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