DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

NCT00157820 | Completed Results DMC

• 1 other identifier: SP-DATAS
• Study Type: interventional
• Target: 354
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Defibrillators, Implantable; Atrial Fibrillation; Ventricular Tachyarrhythmias; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• CSAE-score Rate(Clinical Significant Adverse Events Score Rate)

  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 Outcomes (1)

• Number of Each of the Components of the CSAE

  17 months

Study Arms (3)

SC true

ACTIVE COMPARATOR

Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber.

Device: Single Chamber Implantable Cardioverter Defibrillator

SC sim

EXPERIMENTAL

Dual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'')

Device: Dual Chamber implantable cardioverter defibrilator

DC true

EXPERIMENTAL

Dual chamber ICD initially programmed as a DDED (''DC true arm'').

Device: Dual Chamber implantable cardioverter defibrilator

Interventions

Single Chamber Implantable Cardioverter Defibrillator DEVICE

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

Also known as: Medtronic GEM, Medtronic Marquis family of SC ICD

SC true

Dual Chamber implantable cardioverter defibrilator DEVICE

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

Also known as: Medtronic Jewel AF, Medtronic GemIII AT, DC ICD

DC true; SC sim

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Related Publications (4)

• 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. doi: 10.1016/j.eupc.2003.11.011.

  PMID: 15018874 BACKGROUND

• 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. doi: 10.1093/europace/eun072. Epub 2008 Apr 7.

  PMID: 18390985 RESULT

• Ricci RP, Quesada A, Almendral J, Arribas F, Wolpert C, Adragao P, Zoni-Berisso M, Navarro X, DeSanto T, Grammatico A, Santini M; DATAS study Investigators. Dual-chamber implantable cardioverter defibrillators reduce clinical adverse events related to atrial fibrillation when compared with single-chamber defibrillators: a subanalysis of the DATAS trial. Europace. 2009 May;11(5):587-93. doi: 10.1093/europace/eup072.

  PMID: 19401341 RESULT

• Hadid C, Almendral J, Ortiz M, Schwab JO, Janko S, Mischke K, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E, Navarro X, Quesada A. Incidence, determinants, and prognostic implications of true pleomorphism of ventricular tachycardia in patients with implantable cardioverter-defribillators: a substudy of the DATAS Trial. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):33-42. doi: 10.1161/CIRCEP.110.957068. Epub 2010 Nov 13.

  PMID: 21076160 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The follow-up might have been too short to reveal differences in heart failure-related hospitalizations and related mortality. Premature crossovers are a limitation of RCT. However, our scoring system severely penalized this cross-overs.

Results Point of Contact

• Title: Dr.A.Quesada
• Organization: Hospital General Universitario de Valencia, Spain

aquesadad@secardiologia.es

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2000
• Primary Completion: May 1, 2005
• Study Completion: October 1, 2005
• Last Updated: July 2, 2025
• Results First Posted: August 21, 2012

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share