Personalised Decision Support for Heart Valve Disease

Completed

• Conditions: Heart Valve Diseases
• Interventions: Procedure: Surgical treatment of valvular heart disease; Diagnostic Test: Virtual treatment

• Registration Number: NCT04068740
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-01-20
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-08
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mitral valve disease	Virtual treatment	-
Aortic valve disease	Virtual treatment	-
Mitral valve disease	Surgical treatment of valvular heart disease	-
Aortic valve disease	Surgical treatment of valvular heart disease	-

Primary Outcome Measures

Name	Time	Method
Virtual treatment outcome: model based insufficiency or gradient across the valve	6-12 months after treatment
Survival	6-12 months after treatment
Clinical treatment outcome: Imaging based insufficieny or gradient across the valve	6-12 months after treatment
Probability (in %) of reaching of a patient-specific 6-minute walk distance	6-12 months after treatment	Patient-specific walk test distances are calulated based on known reference standards
6-minute walk test distances	6-12 months after treatment	distances in meters