University of Oulu

EU-CERT-ICD - Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope (602299)

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Description:
An estimated 500.000 sudden cardiac deaths (SCD) occur each year in the European Union. Patients at risk for SCD may benefit from prophylactic treatment with an implantable cardioverter-defibrillator (ICD). ICD implantations have dramatically increased in recent years leading to multi-billion Euros of costs with significant regional disparities across Europe. Information on risks, benefits and costs supporting current guideline recommendations may be outdated, and the influence of gender remains unclear. EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe) aims to generate contemporary clinical outcome data on ICD effectiveness in Europe. Clinical outcomes including all-cause mortality, appropriate and inappropriate ICD shocks, and quality of life (QoL) are assessed by: - a prospective study of patients undergoing indicated ICD treatment for primary SCD prevention, with a control group of patients not undergoing ICD treatment - a large European registry collecting available data on prophylactic ICD treatment - meta-analyses of available and emerging ICD outcome studies QoL-adjusted cost-effectiveness will be estimated from actual cost comparisons and Markov decision models with attention to sub-groups, regional, and sex comparisons. Outcomes in patients receiving ICDs for primary SCD prevention will be compared in sub-strata, and with patients fulfilling guideline criteria but not undergoing therapy as per prior decision of treating physicians. Sub-groups with particularly large or small benefit from ICD implantation will be identified using risk markers and clinical characteristics with specific emphasis on gender. EU-CERT-ICD is expected to provide important novel information to validate or challenge current guideline indications for primary prophylactic ICD treatment.
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Subjects:
Grant Number: 602299
Cordis Record Number: 110067
Project Start Date: 2013-10-01
Project End Date: 2017-09-30
Project Funder: EC/FP7/SP1/HEALTH
EC Special Clause: true
Datapilot: false
Open Access Mandate: true
Coordinator: UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS
Coordinator contact: Hennecke, Christiane
Coordinator EU Contribution: 2200575.64
EU Max Contribution: 5999562
Total Cost: 7700199.69
Participant: MAGDALENA - KLINIKA ZA KARDIOVASKULARNE BOLESTI MEDICINSKOG FAKULTETASVEUCILISTA J.J. STROSSMAYERA U OSIJEKU USTANOVA
SLOVENSKA ZDRAVOTNICKA UNIVERZITA V BRATISLAVE
KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN
REGION HOVEDSTADEN
STREDOSLOVENSKY USTAV SRDCOVYCH A CIEVNYCH CHOROB AS
SEMMELWEIS EGYETEM
SKANE LANS LANDSTING
PANEPISTIMIAKO GENIKO NOSOKOMEIO ATTIKON
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
UNIVERZITA PALACKEHO V OLOMOUCI
OULUN YLIOPISTO
KLINIKEN LUDWIGSBURG-BIETIGHEIM GGMBH
KAROLINSKA INSTITUTET
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG
EBERHARD KARLS UNIVERSITAET TUEBINGEN
ST. PAUL'S CARDIAC ELECTROPHYSIOLOGY LLP
University Hospital Basel
KATHOLIEKE UNIVERSITEIT LEUVEN
INSTYTUT KARDIOLOGII IM. PRYMASA TYSIACLECIA STEFANA KARDYNALA WYSZYNSKIEGO
SZPITAL KLINICZNY IM HELIODORA SWIECICKIEGO UNIWERSYTETU MEDYCZNEGO IMKAROLA MARCINKOWSKIEGO W POZNANIU
FAKULTNI NEMOCNICE BRNO
UNIVERSYTET MEDYCZNY W LODZI.
More information: Detailed project information (CORDIS)
Detailed project information (Openaire)
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