Tachyarrythmias, automatic implantable cardioverter defibrilator (ICD) Circulatory System Tachyarrythmia
Conditions
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.
Sponsors
Medtronic Inc. (USA)
Eligibility
Inclusion criteria
Inclusion criteria: Meet Class I implantation criteria for single chamber implantable cardioverter defibrillator according to guidelines
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany, Israel, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed