CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 354 enrolled
Drug / intervention
Single Chamber Implantable Cardioverter Defibrillator +1 moredevice
Likely dose
Not stated in record
Key inclusion· 1
  • Meet Class I implantation criteria for single chamber ICD per ACC/AHA guidelines
Key exclusion· 7
  • Permanent atrial fibrillation
  • Absence of structural heart disease
  • Meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, 2nd or 3rd degree AV block)
  • Prior ICD or pacemaker implant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00157820
NCT00157820N/ACompleted

DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Sep 12, 2005·Updated Jul 2, 2025

In Brief

A clinical study evaluating Single Chamber Implantable Cardioverter Defibrillator and Dual Chamber implantable cardioverter defibrilator for Ventricular Tachycardia and 2 related conditions. Completed, enrolled 354 participants.

Detailed Summary

The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non selected population with conventional indication of ICD implantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartNov 1, 2000
Primary CompletionMay 1, 2005
Study CompletionOct 1, 2005
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.8 years ago

Interventions

Single Chamber Implantable Cardioverter Defibrillatordevice

Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD

Dual Chamber implantable cardioverter defibrilatordevice

Dual chamber ICD implantation: Jewel AF \& GemIII AT as DC ICDs (DC true and SC sim arms)