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DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

NCT00157820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2025-07-02

Study results available
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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.

Conditions

  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Defibrillators, Implantable

Interventions

DEVICE

Single Chamber Implantable Cardioverter Defibrillator

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

DEVICE

Dual Chamber implantable cardioverter defibrilator

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

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Aurelio Quesada, MD · Hospital General Universitario, Valencia, Spain

  • Jesus Almendral, MD · Hospital General Universitario Gregorio Marañon, Madrid, Spain

  • Fernando Arribas, MD · Hospital Universitario 12 de Octubre, Madrid, Spain

  • Massimo Santini, MD · San Filippo Neri Hospital, Rome, Italy

  • Christian Wolpert, MD · University Hospital Mannheim, Mannheim, Germany

  • Pedro Adragao, MD · Santa Cruz Hospital, Carnaxide, Portugal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Primary Completion
2005-05-31
Completion
2005-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00157820 on ClinicalTrials.gov