The Prospective Clinical Trial

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, and 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) and also from anticipated future pathways, in particular MR imaging which drives the EurValve haemodynamic modelling process and is expected to enter clinical guidelines in due course. Computational model testing will be carried out within a prospective clinical study, the design of which is shown in the Figure below.

The EurValve Patient Information Sheet contains information of what the trial will involve for those taking part.

Activity Monitoring

One part of the EurValve project is for us to understand how people’s daily lives change after surgery, and 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

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.