Personalised Decision Support for Heart Valve Disease

NCT04068740 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 169

Last updated 2019-08-28

No results posted yet for this study

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.

Conditions

  • Heart Valve Diseases

Interventions

PROCEDURE

Surgical treatment of valvular heart disease

Valve replacement or repair

DIAGNOSTIC_TEST

Virtual treatment

Virtual valve replacement or repair surgery

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER
  • Ansys SAS

    collaborator UNKNOWN
  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER
  • Akademia Górniczo-Hutnicza im. Stanisława Staszica

    collaborator UNKNOWN
  • University Rennes

    collaborator UNKNOWN
  • Max-Delbrück-Centrum für Molekulare Medizin

    collaborator UNKNOWN
  • Philips Electronics Nederland BV

    collaborator INDUSTRY
  • Philips Healthcare

    collaborator INDUSTRY
  • Sheffield Teaching Hospitals NHS Foundation Trust

    collaborator OTHER
  • Therenva

    collaborator INDUSTRY
  • Eindhoven University of Technology

    collaborator OTHER
  • University of Bristol

    collaborator OTHER
  • German Heart Institute

    lead OTHER

Principal Investigators

  • Rod Hose, Prof. · University of Sheffield

  • Pim Tonino, Dr. · Stichting Catharina Ziekenhuis

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-20
Primary Completion
2019-01-31
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068740 on ClinicalTrials.gov