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Personalised Decision Support for Heart Valve Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068740
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
University of Sheffield
Ansys SAS
Catharina Ziekenhuis Eindhoven
Akademia Górniczo-Hutnicza im. Stanisława Staszica
University Rennes
Max-Delbrück-Centrum für Molekulare Medizin
Philips Electronics Nederland BV
Philips Healthcare
Sheffield Teaching Hospitals NHS Foundation Trust
Therenva SAS
Eindhoven University of Technology
University of Bristol
Information provided by (Responsible Party):
German Heart Institute

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.


Condition or disease Intervention/treatment
Heart Valve Diseases Procedure: Surgical treatment of valvular heart disease Diagnostic Test: Virtual treatment

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.

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Study Type : Observational
Actual Enrollment : 169 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Combining Multiple Complex Modelling Components to Create a Decision Support System for Heart Valve Disease
Actual Study Start Date : January 20, 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mitral valve disease Procedure: Surgical treatment of valvular heart disease
Valve replacement or repair

Diagnostic Test: Virtual treatment
Virtual valve replacement or repair surgery

Aortic valve disease Procedure: Surgical treatment of valvular heart disease
Valve replacement or repair

Diagnostic Test: Virtual treatment
Virtual valve replacement or repair surgery




Primary Outcome Measures :
  1. Virtual treatment outcome: model based insufficiency or gradient across the valve [ Time Frame: 6-12 months after treatment ]
  2. Clinical treatment outcome: Imaging based insufficieny or gradient across the valve [ Time Frame: 6-12 months after treatment ]
  3. Survival [ Time Frame: 6-12 months after treatment ]
  4. Probability (in %) of reaching of a patient-specific 6-minute walk distance [ Time Frame: 6-12 months after treatment ]
    Patient-specific walk test distances are calulated based on known reference standards

  5. 6-minute walk test distances [ Time Frame: 6-12 months after treatment ]
    distances in meters



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients from Berlin, Sheffield and Eindhoven with heart valve disease and a planned intervention.
Criteria

Inclusion Criteria:

  • The patient must give Informed Consent before being enrolled in the study.
  • Only elective cases will be eligible for inclusion. For mitral disease, patients were recruited with;
  • 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068740


Sponsors and Collaborators
German Heart Institute
University of Sheffield
Ansys SAS
Catharina Ziekenhuis Eindhoven
Akademia Górniczo-Hutnicza im. Stanisława Staszica
University Rennes
Max-Delbrück-Centrum für Molekulare Medizin
Philips Electronics Nederland BV
Philips Healthcare
Sheffield Teaching Hospitals NHS Foundation Trust
Therenva SAS
Eindhoven University of Technology
University of Bristol
Investigators
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Study Chair: Rod Hose, Prof. University of Sheffield
Study Chair: Pim Tonino, Dr. Stichting Catharina Ziekenhuis
  Study Documents (Full-Text)

Documents provided by German Heart Institute:
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Responsible Party: German Heart Institute
ClinicalTrials.gov Identifier: NCT04068740    
Other Study ID Numbers: EurValve
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases