DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study - Full Text View

Sponsor:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00157820

Purpose

The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs (DDED), 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
Implantable Cardioverter-Defibrillators Tachycardia, Ventricular Ventricular Fibrillation	Device: Implantable Cardioverter Defibrillator	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Clinically Significant Adverse Events (all cause mortality, hospitalization...) measured from randomization until 17 m follow-up.

Secondary Outcome Measures:

Number of each of the components of the CSAE
Atrial tachyarrhythmias related (burden, num episodes...)
Ventricle tachyarrhythmias related (burden, number of episodes...)
NYHA, LVEF, CAD, exercise capacity, medication
Quality of live questionnaires
all measured at baseline, 8 months ant 17 months.

Estimated Enrollment:	360
Study Start Date:	November 2000
Estimated Study Completion Date:	April 2005

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 DDED ICD 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":

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

Secondary objectives are:

Number of each of the components of the CSAE.
Arrhythmia related: atrial tachyarrhythmia, frequency and burden, ventricular tachyarrhythmia frequency and burden number of appropriate shocks, number of inappropriate shocks, need for reprogramming, need for medication/RFA for arrhythmia control, pacemaker syndrome and development of dual chamber pacing indication.
Cardiovascular related: NYHA functional class, exercise capacity, left ventricular ejection fraction (LVEF), reduction of medication (diuretics.).
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 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

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:

Quesada A, Almendral J, Arribas F, Ricci R, Wolpert C, Adragao P, Cobo E, Navarro X; DATAS Investigators. The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator. Europace. 2004 Mar;6(2):142-50.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Almendral J, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E, Navarro X, Quesada A; DATAS Steering Committee; DATAS Writing Committee; DATAS Investigators. Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial. Europace. 2008 May;10(5):528-35. Epub 2008 Apr 7.

ClinicalTrials.gov Identifier:	NCT00157820 History of Changes
Other Study ID Numbers:	SP-DATAS
Study First Received:	September 8, 2005
Last Updated:	June 5, 2006
Health Authority:	Spain: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:

Implantable Cardioverter Defibrillators
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 February 09, 2012