1. Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation
- Author
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Axel Bauer, Jarosław D. Kasprzak, Rajeeva Sritharan, Nikola Pavlović, Tomas Novotny, Panagiota Flevari, Jesper Hastrup Svendsen, Vassil Traykov, David Conen, Andrzej Lubiński, Tim Friede, Frieder Braunschweig, Georg Schmidt, Josep Brugada, Markus Zabel, Lars Lüthje, Stefan Kääb, Christian Sticherling, Tchavdar N. Shalganov, Anton E. Tuinenburg, Svetoslav Iovev, Gabriela Kaliska, Heikki V. Huikuri, Rik Willems, Janko Szavits Nossan, Gerd Hasenfuß, Robert Hatala, Stefan N. Willich, Simon Schlögl, Jim Hansen, Sandro Brusich, Milos Taborsky, Marc A. Vos, Béla Merkely, Vasil Velchev, Leonard Bergau, Marek Malik, and Iwona Cygankiewicz
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Comparative effectiveness research ,Guideline ,030204 cardiovascular system & hematology ,medicine.disease ,Implantable cardioverter-defibrillator ,3. Good health ,Sudden cardiac death ,03 medical and health sciences ,0302 clinical medicine ,Emergency medicine ,medicine ,Clinical endpoint ,media_common.cataloged_instance ,030212 general & internal medicine ,European union ,Cardiology and Cardiovascular Medicine ,business ,Prospective cohort study ,Cohort study ,media_common - Abstract
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.
- Published
- 2018