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 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 trial start date
01/11/2000
Overall trial end date
01/04/2005
Reason abandoned (if study stopped)
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
Funders
Funder type
Industry
Funder name
Medtronic
Alternative name(s)
Medtronic Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
See https://clinicaltrials.gov/ct2/show/results/NCT00157820
Publication list
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15018874
Results in http://www.ncbi.nlm.nih.gov/pubmed/18390985
Publication citations
-
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.
-
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.