Comparison of AAIsafeR and DDD Modes in Non-selected Patients

Launched by SORIN GROUP CANADA · Oct 12, 2010

Keywords

ClinConnect Summary

In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers are contraindicated although ventricular support is only rarely needed. As a result, these patients are usually exposed to an unnecessary high proportion of ventricular pacing due to the programming of the system to DDD mode for preventive safety reasons. This drains the pulse generator battery, and more importantly has long-term adverse effects on ventricular function in a su...

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Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria / Indications Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation) may be included in the study.
• Exclusion Criteria:
• • Exclusion criteria / Contraindications
• The patients presenting with one or more of the following characteristics cannot be included:
• • Permanent complete AV block
• • Permanent atrial and/or ventricular arrhythmias
• • already implanted with a cardioverter-defibrillator (ICD)
• * Likely to have a cardiac surgery in the next six months, mainly for:
• • severe coronary artery disease
• • severe valvular disease
• • Refuses to sign an consent form after having received the appropriate information
• • Refuses to co-operate
• • Not able to understand the study objectives and protocol
• • Not available for scheduled follow-up
• • With a life expectancy less than one year
• • Already included into another clinical study competing with the objectives of the CAN-SAVE R study.
• • \<18 years old.
• • Contraindications Any patient to whom a contraindication from device labeling applies shall not be included in the study.
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