MRI Ready IDE Study

• Research type

  Research Study

• Full title

  A Clinical Evaluation of the Durata® or Optisure®™ High Voltage Leads and Ellipse® VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE)

• IRAS ID

  198360

• Contact name

  Nicole Harbert

• Contact email

  nharbert@sjm.com

• Sponsor organisation

  St Jude Medical

• Clinicaltrials.gov Identifier

  NCT02787291

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  The propose of this Investigational Device Exemption (IDE) Study is the assessment (safety and efficacy) of the St Jude Medical market-released Durata® or Optisure® high voltage leads implanted with a market released St. Jude Medical Ellipse single chamber (VR) Implantable Cardioverter Defibrillator (ICD) undergoing Magnetic Resonance Imaging.The subject population includes subjects implanted with the Durata or Optisure lead and Ellipse VR ICD with a standard cardiac tachycardia indication.

• REC name

  West of Scotland REC 4

• REC reference

  16/WS/0051

• Date of REC Opinion

  25 Apr 2016

• REC opinion

  Further Information Favourable Opinion