NCT04068740

Personalised Decision Support for Heart Valve Disease

Combining Multiple Complex Modelling Components to Create a Decision Support System for Heart Valve Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: German Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Valvular Heart Disease currently affects 2.5% of the population, but is overwhelmingly a disease of the elderly and consequently on the rise. It is dominated by two conditions, Aortic Stenosis and Mitral Regurgitation, both of which are associated with significant morbidity and mortality, yet which pose a truly demanding challenge for treatment optimisation. By combining multiple complex modelling components, a comprehensive, clinically-compliant decision-support system will be developed to meet this challenge, by quantifying individualised disease severity and patient impairment, predicting disease progression, ranking the effectiveness of alternative candidate procedures, and optimising the patient-specific intervention plan. In addition the DSS will improve knowledge of disease mechanisms by applying a holistic assessment of cardiovascular function that includes hemodynamic data at all cardiovascular compartments (ventricle, valve, vessels) and multiscale components that couple organ with cell function. DSS may have major impact on patients with borderline indications for treatment (valve replacement/repair), complex hemodynamic conditions such as combined aortic-mitral valve disease and valve geometries that are subject to valve repair. The target user of this Decision Support System is the healthcare professional, in this case the surgeon or cardiologist, who will make the decision on the nature and timing of the intervention. The major advance of this system over current practice is that it integrates and interprets all heterogeneous data available about the patient, integrates population data where needed, and provides a consistent, repeatable, quantitative and auditable record of the information that contributes to the decision process.

Detailed description

Study design: In the study a Decision Support System for aortic and mitral valve replacement/repair will be implemented and tested. Not all of the assessments listed will be performed on every patient, but sufficient to support the analysis processes. The patients are enrolled in two subgroups: * Group 1: patients with aortic valve disease * Group 2: patients with mitral valve disease The study has the following visits at all clinical centers: 1. Visit 1: Patients will be investigated before valve intervention by imaging (MRI, Echocardiography, CT), ECG, laboratory tests, anthropometrics (blood pressure, body weight, clinical status). A subset of patients will wear a fitness tracker for at least one day and perform a 6-minute walk test. 2. Operation (valve replacement/repair): All patients will be treated according to current clinical guidelines. 3. Virtual treatment: Patients will receive a virtual treatment 4. Visit 2: After treatment patients will be followed-up undergoing the study protocol again. This allows comparing the modeled (predicted) against measured outcome data.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
PROCEDURE	Surgical treatment of valvular heart disease	Valve replacement or repair
DIAGNOSTIC_TEST	Virtual treatment	Virtual valve replacement or repair surgery

Timeline

• Start date: 2016-01-20
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2019-08-28
• Last updated: 2019-08-28