© 2004 by European Society of Cardiology
The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator*
aCardiology Department, Hospital General Universitario Valencia, Spain; bDepartment of Cardiology, Hospital General Universitario Gregorio Marańon Madrid, Spain; cArrhythmia Unit, Hospital Universitario 12 de Octubre Madrid, Spain; dHeart Diseases Department, San Filippo Neri Hospital Rome, Italy; e1st Department of Medicine–Cardiology, University Hospital Mannheim Mannheim, Germany; fCardiology Department, Santa Cruz Hospital, Carnaxide, Portugal ; gDepartamento de Estadistica e Investigacion Operativa, Universitat Politecnica de Catalunya Barcelona, Spain; hScientific & Clinical Department Medtronic Ibérica, Spain
Single chamber (SC) implantable cardioverter defibrillators (ICDs) have several limitations that might be relevant during follow-up, like atrial pacing requirements, inadequate therapies, sustained atrial tachyarrhythmias and difficulties to achieve an accurate diagnosis of the arrhythmia. Dual chamber (DC) ICDs offer an attractive and rational solution, although controversy remains if the costs and complexity of these devices offer a real clinical advantage. The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of DC ICD, DDED, to reduce clinically significant adverse events compared with SC ICD in a non-selected population with conventional indications for ICD implantation. This is a prospective, multicentre, randomized, open labelled study, with three arms: two of them (simulated SC ICD and true DC ICD) cross-over, and the third (true SC ICD) parallels the other two. The composite primary end point comprises four Clinically Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention, hospitalization or prolongation of hospitalization due to cardiovascular cause, (3) inappropriate shocks, and (4) sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48 h leading to therapeutic intervention. Secondary end points constitute each of the individual components of CSAE, cardiovascular status, quality of life and a detailed analysis of atrial and ventricular arrhythmias. To date (June 2003) there have been 343 patients enroled from 947 screened patients. The projected enrolment includes 360 patients and the conclusion of the study is expected at the beginning of 2005.
Key Words: implantable cardioverter defibrillators, atrial fibrillation, ventricular tachyarrhythmias, clinical trial
*Corresponding author. C/Gongora 1, 26, Valencia 46015, Spain. E-mail address: quesada_aur{at}gva.es (A. Quesada).
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  J. Almendral, F. Arribas, C. Wolpert, R. Ricci, P. Adragao, E. Cobo, X. Navarro, A. Quesada, and the DATAS Steering Committee and Writing Committee Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial Europace, May 1, 2008; 10(5): 528 - 535. [Abstract] [Full Text] [PDF]
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