Zabel, Markus and Sticherling, Christian and Willems, Rik and Lubinski, Andrzej and Bauer, Axel and Bergau, Leonard and Braunschweig, Frieder and Brugada, Josep and Brusich, Sandro and Conen, David and Cygankiewicz, Iwona and Flevari, Panagiota and Taborsky, Milos and Hansen, Jim and Hasenfuss, Gerd and Hatala, Robert and Huikuri, Heikki V. and Iovev, Svetoslav and Kaeaeb, Stefan and Kaliska, Gabriela and Kasprzak, Jaroslaw D. and Luethje, Lars and Malik, Marek and Novotny, Tomas and Pavlovic, Nikola and Schmidt, Georg and Shalganov, Tchavdar and Sritharan, Rajeeva and Schloegl, Simon and Nossan, Janko Szavits and Traykov, Vassil and Tuinenburg, Anton E. and Velchev, Vasil and Vos, Marc A. and Willich, Stefan N. and Friede, Tim and Svendsen, Jesper Hastrup and Merkely, Bela and Seegers, J. and Munoz-Exposito, P. and Tichelbacker, T. and Kirovo, A. and Sritharan, R. and Joerss, K. and Macken, J. and Misdaq, M. and Rudolph, K. and Schmidt, G. and Mueller, A. and Dommasch, M. and Sinnecker, D. and Sinner, M. and Bauer, A. and Dissmann, R. and Burmester, U. and Behrens, S. and Gregor, M. and Stefanow, S. and Rueb, N. and Wolpert, C. and Bimmel, D. and Lieberz, C. and Seegers, J. and Maier, L. and Schwinger, R. and Blaschke, F. and Pieske, B. and Groenefeld, G. and Klein, G. and Gardiwal, A. and Merkely, B. and Szeplaki, G. and Perge, P. and Nossan, J. Szavits and Rotkvic, L. and Pavlovic, N. and Manola, S. and Vinter, O. and Benko, I. and Brusic, S. and Avdovic, E. and Klasan, M. and Bakotic, Z. and Anic, A. and Lubinski, A. and Kowalczyk, E. and Kucejko, T. and Czechowska, A. and Wybor, K. and Cygankiewicz, I. and Ptaszynski, P. and Kasprzak, J. and Qavoq, H. and Guzik, P. and Krauze, T. and Sterlinski, M. and Hatala, R. and Svetlosak, M. and Kaliska, G. and Martinek, J. and Thamsborg, K. and Hansen, J. and Schloett-Hyldelund, I. M. and Laage-Petersen, J. and Willems, R. and Vandenberk, B. and van Soest, S. and Traykov, V. and Iovev, S. and Shalganov, T. and Sticherling, C. and Conen, D. and Giesebart, S. and Novotny, T. and Kozak, M. and Taborsky, M. and Galuszka, J. and Tuinenburg, A. E. and Wijers, S. and Wijers, S. and Dunnink, A. and Sprenkeler, D. and Brugada, J. and Arbelo, E. and Trucco, E. and Vidorreta, S. and Huikuri, H. and Kentta, T. and Pelli, A. and Huikuri, P. and Koski, P. and Braunschweig, F. and Karlsson, H. and Ersgaard, D. and Platonov, P. and Klingenheben, T. and Scharfe, M. and Reinhold, T. and Cree, M. and Hnatkova, K. and Kentta, T. and Gerhardt, J. and Rizas, K. and Hamm, W. and Roever, C. and Harden, M. and Kessel, B. and Brugada, J. and Berg, A. and Apel, S. and Walker, F. and Kirchhof, N. and Goerlitz, A. and Molitor, A. and Heinrich, J. and Annetzberger, S. and Fuchs, B. and Landwehr, A. and Merk, A. and Wilke, A. and Hennecke, C. and Mansch, R. (2019) Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation. ESC HEART FAILURE, 6 (1). pp. 182-193. ISSN 2055-5822,
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SUDDEN CARDIAC DEATH; CARDIOVERTER-DEFIBRILLATOR THERAPY; SEATTLE HEART-FAILURE; PRIMARY PREVENTION; RISK STRATIFICATION; MYOCARDIAL-INFARCTION; APPROPRIATE SHOCKS; PROPORTIONAL RISK; EJECTION FRACTION; SEX-DIFFERENCES; Implantable cardioverter defibrillator; Risk factors; Mortality; Sudden cardiac death |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 20 Apr 2020 05:23 |
| Last Modified: | 20 Apr 2020 05:23 |
| URI: | https://pred.uni-regensburg.de/id/eprint/27620 |
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