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14 March 2010
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| [ Print-friendly version ] |
| Dual chamber and Atrial Tachyarrhythmias Adverse events Study |
| ISRCTN | ISRCTN82728969 |
| ClinicalTrials.gov identifier | NCT00157820 |
| Public title | Dual chamber and Atrial Tachyarrhythmias Adverse events Study |
| Scientific title | |
| Acronym | DATAS |
| Serial number at source | 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 |
| Countries of recruitment | Germany, Israel, Italy, Portugal, Spain, United Kingdom |
| Disease/condition/study domain | Tachyarrythmias, automatic implantable cardioverter defibrilator (ICD) |
| Participants - inclusion criteria | Meet Class I implantation criteria for single chamber implantable cardioverter defibrillator according to guidelines. |
| Participants - 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 |
| Anticipated start date | 01/11/2000 |
| Anticipated end date | 01/04/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 360 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Medtronic Inc. (USA) |
| Trial website | |
| Publications |
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15018874
Results in http://www.ncbi.nlm.nih.gov/pubmed/18390985 |
| Contact name | Dr Aurelio Quesada |
| Address | Av. Tres Cruces s/n |
| City/town | Valencia |
| Zip/Postcode | 46014 |
| Country | Spain |
| aquesadad@meditex.es | |
| Sponsor | Medtronic Inc. (USA) |
| Address | - |
| City/town | Minneapolis |
| Zip/Postcode | 55432-3576 |
| Country | United States of America |
| Sponsor website: | http://www.medtronic.com/ |
| Date applied | 13/12/2003 |
| Last edited | 11/08/2008 |
| Date ISRCTN assigned | 16/01/2004 |
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