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Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation

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  • Markus Zabel
  • Christian Sticherling
  • Rik Willems
  • Andrzej Lubinski
  • Axel Bauer
  • Leonard Bergau
  • Frieder Braunschweig
  • Josep Brugada
  • Sandro Brusich
  • David Conen
  • Iwona Cygankiewicz
  • Panagiota Flevari
  • Milos Taborsky
  • Jim Hansen
  • Gerd Hasenfuß
  • Robert Hatala
  • Heikki V Huikuri
  • Svetoslav Iovev
  • Stefan Kääb
  • Gabriela Kaliska
  • Jaroslaw D Kasprzak
  • Lars Lüthje
  • Marek Malik
  • Tomas Novotny
  • Nikola Pavlović
  • Georg Schmidt
  • Tchavdar Shalganov
  • Rajeeva Sritharan
  • Simon Schlögl
  • Janko Szavits Nossan
  • Vassil Traykov
  • Anton E Tuinenburg
  • Vasil Velchev
  • Marc A Vos
  • Stefan N Willich
  • Tim Friede
  • Jesper Hastrup Svendsen
  • Béla Merkely
  • EU-CERT-ICD Study Investigators
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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.

Original languageEnglish
JournalESC Heart Failure
Volume6
Issue number1
Pages (from-to)182-193
Number of pages12
ISSN2055-5822
DOIs
Publication statusPublished - 1 Feb 2019

    Research areas

  • 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, Mortality, Implantable cardioverter defibrillator, Sudden cardiac death, Risk factors

ID: 56979200