OSIRIS

• Research type

  Research Study

• Full title

  Observational Study on Inappropriate therapies after Replacement of ICDs

• IRAS ID

  246098

• Contact name

  Gerhard Askhamp

• Contact email

  gerhard.askhamp@crm.microport.com

• Sponsor organisation

  Sorin CRM SAS (Microport CRM)

• Clinicaltrials.gov Identifier

  NCT04118803

• Duration of Study in the UK

  4 years, 4 months, 3 days

• Research summary

  Implantable Cardioverter-defibrillators (ICDs) have been shown to improve mortality in patients with ischemic and non-ischemic cardiomyopathy and those patients who have treatable abnormally fast heart rate disorders. However; patients with ICD's can suffer from problems that affect their daily life. Life saving shocks can be very painful and can have repercussions with patients lifestyles. These shocks can also cause damage to the heart muscle and therefore it is important that any treatment is indeed appropriate. The devices have specialised programming that significantly reduce the risk of inappropriate therapy but one cause that cannot be programmed is that of lead failure. Leads can be implanted for longer than the cans because a can may need replacement without the need to change the lead.
  The OSIRIS clinical investigation will try to assess the incidence of inappropriate shocks and inappropriate Anti Tachycardia Pacing at 2 years, in a population of patients undergoing a generator replacement and Replacement complications to better understand the current trends in Implantable Cardioverter Defibrillator (ICD) patient management.

  A previous study (ISIS) revealed an inappropriate shock rate of 1.9% in Dual Chamber and Cardiac Resynchronisation patients. Further investigation is needed to assess the limitations of this previous study. An interest exists to better define the incidence of inappropriate shocks and their causes in a specific population of patients receiving a generator replacement.
  Analyzing not only shocks but inappropriate Antitachycardia Pacing is also important. Although inappropriate ATP is not harmful to the heart muscle it can trigger an abnormal heart rhythm. Furthermore inappropriate ATP will take up healthcare resource time because of the necessity to invest time to check the actual inappropriate ATP episodes.
  

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  20/WM/0085

• Date of REC Opinion

  13 May 2020

• REC opinion

  Further Information Favourable Opinion