ENABLE MRI

• Research type

  Research Study

• Full title

  Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds\n

• IRAS ID

  189501

• Contact name

  Valerie Lens

• Contact email

  valerie.lens@bsci.com

• Sponsor organisation

  Boston Scientific

• Clinicaltrials.gov Identifier

  NCT02652481

• Duration of Study in the UK

  4 years, 1 months, 2 days

• Research summary

  The ENABLE MRI (Magnetic Resonance Imaging) Study is a dual phase, prospective, non­randomized, confirmatory, global study that will enroll subjects either eligible for implantation with an Implantable Cardioverter Defibrillator (ICD) or with an ICD already implanted. Only ICD models and associated leads and accessories belonging to Boston Scientific’s ImageReady MR Conditional Defibrillation System will be used.\n\nA two phase approach to the study will be employed: \nPhase 1 – New ICD implants and existing implants with a study required MRI scan.\nPhase 2 – Existing ICD implants that require a medically necessary MRI scan.\n\nSubjects will be followed annually (with a recommended follow up interval of 3 months), according to standard of care for a period of 3 years post implant.\n\nThe study will be conducted at up to 60 sites worldwide.\nAt least 500 subjects will be enrolled. 195 subjects in Phase 1 and 305 subjects in Phase 2.\n\nDevices used in the ENABLE MRI Study are all commercially available in Europe.

• REC name

  Wales REC 5

• REC reference

  15/WA/0465

• Date of REC Opinion

  24 Jan 2016

• REC opinion

  Further Information Favourable Opinion