BRADYCARE II

• Research type

  Research Study

• Full title

  Advanced BRADYCARdia Device Feature Utilization and Clinical OutcomEs II

• IRAS ID

  185876

• Contact name

  Oza Ashish

• Contact email

  aoza@sjm.com

• Sponsor organisation

  St Jude Medical

• Duration of Study in the UK

  2 years, 6 months, 14 days

• Research summary

  When someone has a slow heart beat caused by a medical condition, a pacemaker is implanted to treat it. Cardiac pacemakers stimulate the heart with an electrical impulse causing contraction of the heart and make the heart beat at the normal rate.
  Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity. These advancements include automated capture, automated sensing, patient alert functions, algorithms minimizing ventricular (main pumping chamber) pacing, automatic mode switching in response to atrial tachyarrhythmia, rate responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (RF) technology. However, little information is available on how these new features are being utilized by physicians in the real world, especially in countries outside the USA, and how these features impact patient outcomes.3-8
  Many patients who receive pacemakers will go through natural changes in their disease state and lifestyle that may warrant changes in the way their pacemaker is programmed. St. Jude Medical pacemakers have the ability to identify clinical arrhythmias and provide a wide variety of programming options to address changing clinical status.
  This observational study is designed to gain a better understanding of how diagnostic capabilities in the Accent MRI™, Assurity MRI™, Endurity MRI™, or other St. Jude Medical MRI compatible pacemakers are being utilized to manage patients. Pacemaker information and health status will be collected for all patients enrolled in this study. The insight obtained from the device and clinical data collected in this study could lead to potential improvements in device parameter nominal settings. Furthermore, through this study, new insights may be obtained about the progression of heart disease in bradycardia patients and how the flexibility of programming and diagnostic capabilities can benefit the changing clinical status of these patients.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  15/YH/0364

• Date of REC Opinion

  14 Oct 2015

• REC opinion

  Further Information Favourable Opinion