Condition category
Circulatory System
Date applied
13/12/2003
Date assigned
16/01/2004
Last edited
21/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Aurelio Quesada

ORCID ID

Contact details

Av. Tres Cruces s/n
Valencia
46014
Spain
-
aquesadad@meditex.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00157820

Protocol/serial number

DATAS

Study information

Scientific title

Dual chamber and Atrial Tachyarrhythmias Adverse events Study

Acronym

DATAS

Study hypothesis

To analyse the ability of dual chamber implantable cardioverter defibrillator (DC ICD) (dual chamber [DDED] defibrillator) to reduce clinically significant adverse events compared with single chamber implantable cardioverter defibrillator (SC ICD) in a non-selected population with conventional indications for implantable cardioverter defibrillator (ICD) implantation.

Ethics approval

Documented approval of the investigational plan by the Institutional Review Board (IRB) or Ethics Committee (EC) affiliated with the study centre is required for starting the study.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tachyarrythmias, automatic implantable cardioverter defibrilator (ICD)

Intervention

Interventions:
Analyse the ability of DDED to reduce clinically significant adverse events as compared to SC ICD (VVEV) in a non selected population with conventional indication of ICD implantation.

Three arms: two of them (SC simulated and DC true) cross-over, and the third (SC true) parallels the other two. A 1-month wash out period after the cross-over is included to avoid influence of the remodeling associated with pacing mode.

Patients will be followed-up at 1, 4, 8, 9, 13 and 17 months. At enrolment, 8 and 17 months, the quality of life questionnaires, a 6-minute walk test and echo parameters will be recorded, as well as reevaluation of the cardiovascular history.

Intervention type

Device

Phase

Drug names

Primary outcome measures

To determine whether use of DDED ICD results in a significant decrease in the number of clinically significant adverse events (CSAE) as follows:
1. All-cause mortality
2. Invasive intervention, hospitalisation (greater than 24 hours) or prolongation of hospitalisation due to cardiovascular cause
3. Inappropriate shocks (two or more episodes with inappropriate shocks)
4. Sustained symptomatic atrial tachyarrhythmias that:
4.1. Require urgent termination, or
4.2. Last more than 48 hours leading to therapeutic intervention

Secondary outcome measures

1. Number of each of the components of the CSAE
2. Arrhythmia related:
2.1. Atrial tachyarrhythmia
2.2. Frequency and burden
2.3. Ventricular tachyarrhythmia frequency and burden number of appropriate shocks
2.4. Number of inappropriate shocks
2.5. Need for reprogramming
2.6. Need for medication/radiofrequency ablation (RFA) for arrhythmia control
2.7. Pacemaker syndrome
2.8. Development of dual chamber pacing indication
3. Cardiovascular related:
3.1. New York Heart Association (NYHA) functional class
3.2. Exercise capacity
3.3. Left ventricular ejection fraction (LVEF)
3.4. Reduction of medication (diuretics)
4. Quality of life:
4.1. Evaluated by the 36-item Short Form Health Survey (SF-36)
4.2. Minnesota living test, with heart failure and Symptom Checklist instruments

Overall trial start date

01/11/2000

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Meet Class I implantation criteria for single chamber implantable cardioverter defibrillator according to guidelines

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

360

Participant exclusion criteria

1. Permanent atrial fibrillation
2. Non structural heart disease
3. Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd atrioventricular (AV) block [except asymptomatic Mobitz I] and all 3rd degree AV block)
4. Previous system implanted (ICD or pacemaker)
5. Mechanical right heart valve
6. Medical conditions that would preclude the testing required by the protocol, or limit study participation
7. Unwilling or unable to cooperate or give written informed consent, or the patient is a minor and legal guardians refuse to give informed consent
8. Inaccessible for follow-up at the study centre
9. Biventricular stimulation or re-synchronisation
10. Enrolled or planning to enrol in other clinical trials during the clinical study

Recruitment start date

01/11/2000

Recruitment end date

01/04/2005

Locations

Countries of recruitment

Germany, Israel, Italy, Portugal, Spain, United Kingdom

Trial participating centre

Av. Tres Cruces s/n
Valencia
46014
Spain

Sponsor information

Organisation

Medtronic Inc. (USA)

Sponsor details

-
Minneapolis
+1 (0)55432-3576
United States of America

Sponsor type

Industry

Website

http://www.medtronic.com/

Funders

Funder type

Industry

Funder name

Medtronic

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00157820

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15018874
Results in http://www.ncbi.nlm.nih.gov/pubmed/18390985

Publication citations

  1. Protocol

    Quesada A, Almendral J, Arribas F, Ricci R, Wolpert C, Adragao P, Cobo E, Navarro X, , The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator., Europace, 2004, 6, 2, 142-150, doi: 10.1016/j.eupc.2003.11.011.

  2. Results

    Almendral J, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E, Navarro X, Quesada A, , , , 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, 10, 5, 528-535, doi: 10.1093/europace/eun072.

Additional files

Editorial Notes

21/03/2016: added link to results - basic reporting.