Document Detail


The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator.
MedLine Citation:
PMID:  15018874     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 48h 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 enrollment includes 360 patients and the conclusion of the study is expected at the beginning of 2005.
Authors:
Aurelio Quesada; Jesús Almendral; Fernando Arribas; Renato Ricci; Christian Wolpert; Pedro Adragao; Eric Cobo; Xavier Navarro;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology     Volume:  6     ISSN:  1099-5129     ISO Abbreviation:  Europace     Publication Date:  2004 Mar 
Date Detail:
Created Date:  2004-03-15     Completed Date:  2004-06-25     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  100883649     Medline TA:  Europace     Country:  England    
Other Details:
Languages:  eng     Pagination:  142-50     Citation Subset:  IM    
Affiliation:
Cardiology Department, Hospital General Universitario, Valencia, Spain. quesada_aur@gva.es
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MeSH Terms
Descriptor/Qualifier:
Arrhythmia, Sinus / therapy
Arrhythmias, Cardiac / mortality,  therapy*
Cardiac Pacing, Artificial / methods
Cross-Over Studies
Defibrillators, Implantable* / adverse effects
Equipment Design
Heart Block / therapy
Humans
Prospective Studies
Research Design
Time Factors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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