Personalised Decision Support for Heart Valve Disease

NCT04068740 | Completed

• 1 other identifier: EurValve
• Study Type: observational
• Target: 169
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• Virtual treatment outcome: model based insufficiency or gradient across the valve

  6-12 months after treatment

• Clinical treatment outcome: Imaging based insufficieny or gradient across the valve

  6-12 months after treatment

• Survival

  6-12 months after treatment

• Probability (in %) of reaching of a patient-specific 6-minute walk distance

  Patient-specific walk test distances are calulated based on known reference standards

  6-12 months after treatment

• 6-minute walk test distances

  distances in meters

  6-12 months after treatment

Study Arms (2)

Mitral valve disease

Procedure: Surgical treatment of valvular heart disease; Diagnostic Test: Virtual treatment

Aortic valve disease

Procedure: Surgical treatment of valvular heart disease; Diagnostic Test: Virtual treatment

Interventions

Surgical treatment of valvular heart disease PROCEDURE

Valve replacement or repair

Aortic valve disease; Mitral valve disease

Virtual treatment DIAGNOSTIC_TEST

Virtual valve replacement or repair surgery

Aortic valve disease; Mitral valve disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients from Berlin, Sheffield and Eindhoven with heart valve disease and a planned intervention.

You may qualify if:

• The patient must give Informed Consent before being enrolled in the study.
• Severe degenerative or functional mitral regurgitation with the need for MVR according to the ESC/EACTS guidelines.
• Degenerative mitral regurgitation
• symptomatic patients with LVEF \>30% and LVESD \< 55mm (I B)
• asymptomatic patients with LV dysfunction (LVESD ≥45 mm and/or LVEF ≤60% (I C)
• asymptomatic patients with LVEF \> 50%, new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure at rest \>50 mmHg) (IIa C)
• patients with severe LV dysfunction (LVEF \< 30% and LVESD \> 55 mm) refractory to medical therapy with high likelihood of durable repair and low comorbidity. (IIa C) Functional mitral regurgitation
• patients with severe MR (EROA \>= 20 mm², Regurgitation volume \> 30 ml) undergoing CABG, and LVEF \>30% (I C)
• patients with moderate MR undergoing CABG (IIa C)
• symptomatic patients with severe MR, LVEF \< 30 %, option for revascularisation, and evidence of viability (IIa C) For aortic valve disease, patients will be recruited with;
• Severe acquired degenerative aortic valve disease with the need for SAVR or TAVI according to the ESC/EACTS guidelines Severe Aortic stenosis
• symptomatic patients (I B)
• patients undergoing CABG or surgery of ascending aorta or another valve (I C)
• asymptomatic patients with abnormal exercise test (I C) / LVEF \< 50% (I C) / blood pressure drop on exercise / peak gradient \> 5.5 m/sec ( (IIa C)
• symptomatic patients with low flow, low gradient (\< 40mmHg) and normal LVEF (IIa C)

You may not qualify if:

• Inability or unwillingness to give formal consent.
• Emergency interventions
• Active infective valvular disease or evidence of valvular damage by recent endocarditis
• Valvular malfunction directly associated with aortic root disease
• Aortic regurgitation as leading aortic valve pathology
• Inability or unwillingness to complete follow up
• MRI contraindications (Implanted pacemaker, Metallic foreign body, Severe claustrophobia)
• CT contraindications (Known iodine or contrast agent allergy, Hyperhidrosis, Pregnancy)

Sponsors & Collaborators

• German Heart Institute: lead
• University of Sheffield: collaborator
• Ansys SAS: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Akademia Górniczo-Hutnicza im. Stanisława Staszica: collaborator
• University Rennes: collaborator
• Max-Delbrück-Centrum für Molekulare Medizin: collaborator
• Philips Electronics Nederland BV: collaborator
• Philips Healthcare: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Therenva: collaborator
• Eindhoven University of Technology: collaborator
• University of Bristol: collaborator

Related Publications (1)

• Berndt N, Eckstein J, Wallach I, Nordmeyer S, Kelm M, Kirchner M, Goubergrits L, Schafstedde M, Hennemuth A, Kraus M, Grune T, Mertins P, Kuehne T, Holzhutter HG. CARDIOKIN1: Computational Assessment of Myocardial Metabolic Capability in Healthy Controls and Patients With Valve Diseases. Circulation. 2021 Dec 14;144(24):1926-1939. doi: 10.1161/CIRCULATIONAHA.121.055646. Epub 2021 Nov 11.

  PMID: 34762513 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rod Hose, Prof.

  University of Sheffield

  STUDY CHAIR

• Pim Tonino, Dr.

  Stichting Catharina Ziekenhuis

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 28, 2019
• Study Start: January 20, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share