AIMS: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

2nd Department of Cardiology Attikon University Hospital Athens Greece

Chair and Department of Cardiology Bieganski Hospital Medical University of Lodz Lodz Poland

Department of Cardiology Acibadem City Clinic Tokuda Hospital Sofia Bulgaria

Department of Cardiology and Pneumology Heart Center University Medical Center Göttingen Germany

Department of Cardiology Karolinska Institutet Stockholm Sweden

Department of Cardiology KBC Sestre Milosrdnice Zagreb Croatia

Department of Cardiology Klinikum Großhadern Ludwig Maximilians Universität Munich Munich Germany

Department of Cardiology Magdalena Klinika Krapinske Toplice Croatia

Department of Cardiology Medical University of Lodz WAM Hospital Lodz Poland

Department of Cardiology National Heart Hospital Sofia Bulgaria

Department of Cardiology Semmelweis University Heart Center Budapest Hungary

Department of Cardiology St Anna Hospital Sofia Bulgaria

Department of Cardiology St Ekaterina University Hospital Sofia Bulgaria

Department of Cardiology SUSSCH Banska Bystrica Slovakia

Department of Cardiology The Heart Centre Rigshospitalet Copenhagen University Hospital and Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Department of Cardiology University Hospital Basel Switzerland

Department of Cardiology University Hospital Olomouc Czech Republic

Department of Cardiology University Medical Center Utrecht Utrecht The Netherlands

Department of Cardiovascular Disease KBC Rijeka Rijeka Croatia

Department of Cardiovascular Sciences University of Leuven Belgium

Department of Electrocardiology Medical University of Lodz Lodz Poland

Department of Internal Medicine and Cardiology University Hospital Brno Brno Czech Republic

Department of Medical Physiology University Medical Center Utrecht Utrecht The Netherlands

Department of Medical Statistics University Medical Center Göttingen Göttingen Germany

DZHK partner site Göttingen Göttingen Germany

Gentofte Hospital Copenhagen Denmark

IDIBAPS Department of Cardiology Hospital Clinic Barcelona Barcelona Spain

Institute for Social Medicine Epidemiology and Health Economics Charité Universitätsmedizin Berlin Berlin Germany

Med Klinik und Poliklinik 1 Technische Universität München Klinikum rechts der Isar Munich Germany

Medical Research Center Oulu University Hospital and University of Oulu Oulu Finland

National Heart and Lung Institute Imperial College London UK

Population Health Research Institute McMaster University Hamilton ON Canada

Slovak Medical University NUSCH Bratislava Slovakia

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ESC Heart Fail. 2019 Aug;6(4):899. doi: 10.1002/ehf2.12444. PubMed

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