DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS)

March 9, 2017 updated by: Medtronic Bakken Research Center
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 Overview

Detailed Description

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 rationale solution, although controversy remains if the costs and complexity of the implants offer a real clinical advantage.

The DATAS is a, prospective, multicentre, randomized, open labelled study, with three arms (two of them cross-over and the third parallels the other two)

The primary objective of this trial is to determine whether use of Dual Chamber ICD (DDED-DDDR NASPE/BPEG Defibrillator/Pacemaker Codes) results in a significant decrease in the number of primary end points.

The primary end point is a composite comprising four so-denominated "Clinically Significant Adverse Events (CSAE)":

  1. all-cause mortality
  2. invasive intervention, hospitalization (>24 h) or prolongation of hospitalization due to cardiovascular cause
  3. inappropriate shocks (two or more episodes with inappropriate shocks)
  4. sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48 h leading to therapeutic intervention.

Secondary objectives are:

  1. Number of each of the components of the CSAE.
  2. Arrhythmia related: atrial tachyarrhythmia (AT), frequency and burden, ventricular tachyarrhythmia frequency and burden number of appropriate shocks, number of inappropriate shocks, need for reprogramming, need for medication/Radiofrequency Ablation (RFA) for arrhythmia control, pacemaker syndrome and development of dual chamber pacing indication.
  3. Cardiovascular related: New York Health Association (NYHA) functional class, exercise capacity, left ventricular ejection fraction (LVEF), reduction of medication (diuretics.).
  4. Quality of life: evaluated by the SF-36, Minnesota living test, with heart failure and Symptom Checklist instruments.

Study Type

Interventional

Enrollment (Actual)

354

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet the Class I implantation criteria for single chamber implantable cardioverter defibrillator according to the guidelines (ACC/AHA).

Exclusion Criteria:

  • Permanent atrial fibrillation
  • Patients without structural heart disease
  • Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd Atrio-Ventricular (AV) block [except asymptomatic Mobitz I] and all 3rd degree AV block ).
  • Patient with previous system implanted (ICD or pacemaker).
  • Patients with biventricular stimulation or re-synchronization.
  • Patient has a mechanical right heart valve.
  • Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation.
  • Patient is unwilling or unable to cooperate or give written informed consent, or the patient is a minor and legal guardians refuse to give informed consent.
  • Patient is or will be inaccessible for follow-up at the study center.
  • Patients who are enrolled or planning to enroll in other clinical trials during the clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SC true
Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber.
Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD
Other Names:
  • Medtronic GEM, Medtronic Marquis family of SC ICD
Experimental: SC sim
Dual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'')
Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)
Other Names:
  • Medtronic Jewel AF, Medtronic GemIII AT, DC ICD
Experimental: DC true
Dual chamber ICD initially programmed as a DDED (''DC true arm'').
Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)
Other Names:
  • Medtronic Jewel AF, Medtronic GemIII AT, DC ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
Time Frame: 17 months
Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.
17 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Each of the Components of the CSAE
Time Frame: 17 months

The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.

Number of each of the components of CSAE, counts the number of events for each pre-determined level.

17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aurelio Quesada, MD, Hospital General Universitario, Valencia, Spain
  • Principal Investigator: Jesus Almendral, MD, Hospital General Universitario Gregorio Marañón, Madrid, Spain
  • Principal Investigator: Fernando Arribas, MD, Hospital Universitario 12 de Octubre, Madrid, Spain
  • Principal Investigator: Massimo Santini, MD, San Filippo Neri Hospital, Rome, Italy
  • Principal Investigator: Christian Wolpert, MD, University Hospital Mannheim, Mannheim, Germany
  • Principal Investigator: Pedro Adragao, MD, Santa Cruz Hospital, Carnaxide, Portugal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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