Key result
Dual chamber ICDs are being compared to single chamber ICDs in the DATAS trial, which has enrolled 343 patients to assess reductions in clinically significant adverse events.
Why the study?
Does dual chamber ICD reduce clinically significant adverse events compared with single chamber ICD in patients with conventional indications for ICD implantation?
RCT (n=343)
Open-label
Cross-over and parallel
Yes
Does dual chamber ICD reduce clinically significant adverse events compared with single chamber ICD in patients with conventional indications for ICD implantation?
Answers are grounded in this paper and cite their sources.
The DATAS trial is designed to evaluate whether dual-chamber ICDs reduce clinically significant adverse events compared to single-chamber ICDs in patients with standard ICD indications.
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.
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Quesada et al. (2004) conducted an RCT in Conventional indications for ICD implantation (n=343). Dual chamber (DC) ICD vs. Single chamber (SC) ICD was evaluated on Composite of all-cause mortality, cardiovascular invasive intervention or hospitalization, inappropriate shocks, and sustained symptomatic atrial tachyarrhythmias. Dual chamber ICDs are being compared to single chamber ICDs in the DATAS trial, which has enrolled 343 patients to assess reductions in clinically significant adverse events.
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