DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

NCT ID: NCT00157820

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2005-10-31

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.

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.

Conditions

Ventricular Tachycardia; Ventricular Fibrillation; Defibrillators, Implantable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SC true

Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber.

Group Type: ACTIVE_COMPARATOR

Single Chamber Implantable Cardioverter Defibrillator

Intervention Type: DEVICE

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

SC sim

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

Group Type: EXPERIMENTAL

Dual Chamber implantable cardioverter defibrilator

Intervention Type: DEVICE

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

DC true

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

Group Type: EXPERIMENTAL

Dual Chamber implantable cardioverter defibrilator

Intervention Type: DEVICE

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

Interventions

Single Chamber Implantable Cardioverter Defibrillator

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

Intervention Type: DEVICE

Dual Chamber implantable cardioverter defibrilator

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

Intervention Type: DEVICE

Other Intervention Names

Medtronic GEM, Medtronic Marquis family of SC ICD; Medtronic Jewel AF, Medtronic GemIII AT, DC ICD

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurelio Quesada, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario, Valencia, Spain

Jesus Almendral, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañon, Madrid, Spain

Fernando Arribas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre, Madrid, Spain

Massimo Santini, MD

Role: PRINCIPAL_INVESTIGATOR

San Filippo Neri Hospital, Rome, Italy

Christian Wolpert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Mannheim, Mannheim, Germany

Pedro Adragao, MD

Role: PRINCIPAL_INVESTIGATOR

Santa Cruz Hospital, Carnaxide, Portugal

References

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.

Reference Type: BACKGROUND

PMID: 15018874 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18390985 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19401341 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21076160 (View on PubMed)

Other Identifiers

SP-DATAS

Identifier Type: -

Identifier Source: org_study_id