Proof of Concept of Model Based Cardiovascular Prediction

Status Enrolling by invitation

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.

Clinical Trial Description

n/a

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02591940
Study type	Observational
Source	German Heart Institute
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	November 2013
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04149600` - Identification of Genetic Causes of Calcific Aortic Valve Disease
Recruiting	`NCT06001489` - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy	N/A
Not yet recruiting	`NCT04430972` - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Completed	`NCT02467062` - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.	N/A
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Terminated	`NCT02128841` - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.	Phase 2
Active, not recruiting	`NCT01194362` - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting	`NCT05975567` - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting	`NCT06025149` - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed	`NCT05082337` - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures	N/A
Completed	`NCT05193760` - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting	`NCT05941455` - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve	N/A
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting	`NCT03924661` - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed	`NCT04073875` - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting	`NCT03121053` - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement	Phase 4
Completed	`NCT02000544` - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit	N/A
Completed	`NCT02981004` - PAR I - Patient-to-Annulus Relation I
Completed	`NCT02688153` - EDWARDS INTUITY Valve System CADENCE Study	N/A
Recruiting	`NCT06126367` - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease