An observational study in Cardiovascular Modeling, Aortic Coarctation and Aortic Valve Disease, sponsored by German Heart Institute. Status unknown. Per ClinicalTrials.gov, last updated 2015-10-30.
Sponsored by German Heart Institute · Observational
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →German Heart Institute is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with the need for surgical or interventional treatment with Aortic Coarctation, as well as patients with the need for aortic valve disease surgery, both according to current treatment guidelines.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
patients with the need for aortic valve disease surgery
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
interventional treatment in heart catheter (stenting/angioplasty) surgical repair of coarctation
Procedure: Surgery or Treatment by Heart Catheter
surgical repair in aortic valve disease (reconstruction/valve replacement)
Procedure: Surgery or Treatment by Heart Catheter
Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment
Time frame: 1 week up to 1 year
Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome)
Time frame: 1 week up to 1 year
Calculated Vessle comliance
Time frame: 1 week up to 1 year
Calculated External and Internal Heart Power
Time frame: 1 week up to 1 year
Number of Participants with Aortic Coarctation with Arterial Hypertension
Time frame: 1 week up to 1 year
No study locations are listed for this record.
The record gives a start of Nov 2013, a primary completion of Dec 2015 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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German Heart Institute