DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00157820
First received: September 8, 2005
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Ventricular Tachycardia
Ventricular Fibrillation
Defibrillators, Implantable
Device: Implantable Cardioverter Defibrillator (ICD)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • CSAE-score Rate(Clinical Significant Adverse Events Score Rate) [ Time Frame: 17 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Each of the Components of the CSAE [ Time Frame: 17 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 354
Study Start Date: November 2000
Study Completion Date: October 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SC true
Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber.
Device: Implantable Cardioverter Defibrillator (ICD)
Single Chamber (SC) and Dual Chamber (DC) ICD
Other Names:
  • Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)
  • GEM & Marquis family of SC ICDs (SC true arm)
  • Medtronic Inc.
Experimental: SC sim
Dual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'')
Device: Implantable Cardioverter Defibrillator (ICD)
Single Chamber (SC) and Dual Chamber (DC) ICD
Other Names:
  • Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)
  • GEM & Marquis family of SC ICDs (SC true arm)
  • Medtronic Inc.
Experimental: DC true
Dual chamber ICD initially programmed as a DDED (''DC true arm'').
Device: Implantable Cardioverter Defibrillator (ICD)
Single Chamber (SC) and Dual Chamber (DC) ICD
Other Names:
  • Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)
  • GEM & Marquis family of SC ICDs (SC true arm)
  • Medtronic Inc.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157820

Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Aurelio Quesada, MD Hospital General Universitario, Valencia, Spain
Principal Investigator: Jesus Almendral, MD Hospital General Universitario Gregorio Marañon, 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
  More Information

Publications:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00157820     History of Changes
Other Study ID Numbers: SP-DATAS
Study First Received: September 8, 2005
Results First Received: March 10, 2011
Last Updated: July 17, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:
Defibrillators, Implantable
Atrial Fibrillation
Ventricular Tachyarrhythmias
Clinical Trial

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014