UNTOUCHED

• Research type

  Research Study

• Full title

  Understanding Outcomes with the EMBLEM™ S-ICD in Primary Prevention Patients with Low Ejection Fraction (UNTOUCHED)

• IRAS ID

  177000

• Contact name

  Craig Scott Barr

• Contact email

  craigbarr@nhs.net

• Sponsor organisation

  Boston Scientific

• Duration of Study in the UK

  6 years, 1 months, 16 days

• Research summary

  The UNTOUCHED Study is a global, multi-site, prospective, non-randomized study that will enroll subjects eligible for implantation with an EMBLEM S-ICD System and who also have:
  - an indication for primary prevention of sudden cardiac death; and
  - a left ventricular ejection fraction ≤ 35%.

  Subjects will be followed semi-annually according to standard of care for a minimum of 18 months post implant.

  The study will be conducted at up to 200 sites worldwide.
  At least 2015 subjects will be enrolled.

  Devices used in the UNTOUCHED study are all commercially available.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  15/EM/0179

• Date of REC Opinion

  18 May 2015

• REC opinion

  Further Information Favourable Opinion