Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation.
Cardiomyopathy, Dilated
/ complications
Death, Sudden, Cardiac
/ epidemiology
Defibrillators, Implantable
Electrocardiography
Europe
/ epidemiology
Follow-Up Studies
Humans
Patient Selection
Primary Prevention
/ methods
Prospective Studies
Quality of Life
Risk Assessment
Survival Rate
/ trends
Treatment Outcome
Implantable cardioverter defibrillator
Mortality
Risk factors
Sudden cardiac death
Journal
ESC heart failure
ISSN: 2055-5822
Titre abrégé: ESC Heart Fail
Pays: England
ID NLM: 101669191
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
15
08
2018
accepted:
30
08
2018
pubmed:
10
10
2018
medline:
16
3
2019
entrez:
10
10
2018
Statut:
ppublish
Résumé
The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value. The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years. The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.
Identifiants
pubmed: 30299600
doi: 10.1002/ehf2.12367
pmc: PMC6351896
doi:
Types de publication
Comparative Study
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
182-193Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.
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