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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02591940
Other study ID # Cardioproof
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 27, 2015
Last updated October 29, 2015
Start date November 2013
Est. completion date December 2016

Study information

Verified date October 2015
Source German Heart Institute
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous virtual physiological human (VPH) projects and checks the applicability and effectiveness of available predictive modelling and simulation tools, validating them in interrelated clinical trials conducted in three European centres of excellence in cardiac treatment (from Germany, Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and aortic coarctation, which, if left untreated, can ensue irreversible heart failure. As a result treatment becomes mandatory, but optimum timing and the best type of treatment still remain difficult to determine. With more than 50.000 interventions per year within the EU, the diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters, without benefiting, as yet, from patient-specific disease modelling based prediction. CARDIOPROOF goes beyond the current state of the art by conducting validation trials aimed at covering and comparing the complete spectrum of cardiovascular treatment, predicting the evolution of the disease and the immediate and mid-term outcome of treatment. Operational clustering is going to provide a seamless clinical solution that applies different modeling methods to realize the potential of personalised medicine taking into account user-friendliness as a key component of clinical usability. CARDIOPROOF's goal is to provide first-hand data on comparative cost-effectiveness and clinical efficacy of the most advanced VPH approaches compared to conventional diagnostics and treatment algorithms, thus accelerating the deployment of VPH methods in clinical environments, and bring to maturity holistic patient-specific computer-based predictive models and simulations.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 140
Est. completion date December 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with the need for surgical or interventional treatment with Aortic Coarctation

- patients with the need for aortic valve disease surgery

- both according to current treatment guidelines

Exclusion Criteria:

- contraindications for MRI

Study Design

Time Perspective: Prospective


Intervention

Procedure:
Surgery or Treatment by Heart Catheter


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
German Heart Institute Bambino Gesù Hospital and Research Institute, University College, London

Outcome

Type Measure Description Time frame Safety issue
Primary Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment 1 week up to 1 year No
Primary Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome) 1 week up to 1 year No
Secondary Calculated Vessle comliance 1 week up to 1 year No
Secondary Calculated External and Internal Heart Power 1 week up to 1 year No
Secondary Number of Participants with Aortic Coarctation with Arterial Hypertension 1 week up to 1 year No
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