Registries
Automaticity: design of a registry to assess long-term acceptance and clinical impact of Automatic Algorithms in Insignia pacemakers
1 Amphia Ziekenhuis, Molengracht 21, 4818 CK Breda, The Netherlands; 2 Boston Scientific Corporation, St Paul, MN, USA
Aims: Worldwide, the number of implants of pacemakers is steadily increasing and this poses an incremental burden on outpatient clinics. While device manufacturers have developed safe and effective automatic algorithms to lighten this workload, the clinical utilization of these algorithms has not been well studied. The Automaticity study is the first large-scale, worldwide registry to evaluate physician's acceptance of automatic algorithms for ventricular capture, automatic sensing, and automatic optimization of sensor settings. The primary objective of the registry is to determine the percentage of patients who have any of the ‘Automaticity Algorithms’ reprogrammed within 12 months of pacemaker implant.
Methods: Patients will be implanted with a commercially available pacemaker (Insignia ITM/Nexus ITM Ultra or Insignia ITM/Nexus ITM AVT, Boston Scientific CRM, St Paul, MN, USA). At discharge, all the ‘Automaticity Algorithms’ are to be programmed to ‘Auto/On’. Data collection on changes in device programming, physician's perception of algorithm function, and adverse events will occur for 12 months following device implant.
Conclusion: The Automaticity study is the first large-scale, prospective, multi-site, international registry designed to assess the long-term acceptance of automatic pacemaker algorithms for adjustment of the ventricular output, atrial and ventricular sensitivity, and optimization of minute ventilation and accelerometer settings.
Key Words: Pacing, Pacemaker, Algorithms, Registry, Automaticity
* Corresponding author. Tel: +31 76 595 3000, Fax: +31 76 595 3340, Email: malings{at}amphia.nl
Manuscript submitted 11 September 2008. Accepted after revision 7 January 2009.