Dual chamber and atrial tachyarrhythmias adverse events study

ISRCTN	ISRCTN82728969
DOI	https://doi.org/10.1186/ISRCTN82728969
ClinicalTrials.gov number	NCT00157820
Secondary identifying numbers	DATAS

Submission date: 13/12/2003
Registration date: 16/01/2004
Last edited: 21/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Aurelio Quesada
Scientific

Av. Tres Cruces s/n
Valencia
46014
Spain

Email	aquesadad@meditex.es

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Dual chamber and Atrial Tachyarrhythmias Adverse events Study
Study acronym	DATAS
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/11/2000
Completion date	01/04/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	360
Key inclusion criteria	Meet Class I implantation criteria for single chamber implantable cardioverter defibrillator according to guidelines
Key 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
Date of first enrolment	01/11/2000
Date of final enrolment	01/04/2005

Locations

Countries of recruitment

Germany
Israel
Italy
Portugal
Spain
United Kingdom

Study participating centre

Av. Tres Cruces s/n

Valencia
46014
Spain

Sponsor information

Medtronic Inc. (USA)
Industry

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

Website	http://www.medtronic.com/
"ROR"	https://ror.org/00grd1h17

Funders

Funder type

Industry

Medtronic
Private sector organisation / For-profit companies (industry)

Alternative name(s): Medtronic Inc.
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Basic results			No	No
Protocol article	Protocol	01/03/2004	Yes	No
Results article	Results	01/05/2008	Yes	No

Editorial Notes

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