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Reveal LINQ™ In-Office 2 (RIO 2) International Study

  • Research type

    Research Study

  • Full title

    Reveal LINQ™ In-Office 2 (RIO 2) International Study

  • IRAS ID

    184928

  • Contact name

    Angelic Goode

  • Contact email

    Angelic.Goode@bfwhospitals.nhs.uk

  • Clinicaltrials.gov Identifier

    NCT02412488

  • Duration of Study in the UK

    1 years, 9 months, 2 days

  • Research summary

    Syncope (fainting) is a common cause of patients visiting their GPs and A&E departments. It can occur as a result of multiple conditions, and finding its exact cause can be difficult. Amongst the causes of syncope, there are a number of irregular heart rhythms that can lead to it. When a doctor suspects that this could be the case there are a number of tools (diagnostic tests) that they can use to help confirm this. The Reveal LinQ device is one of these tools.

    The Reveal LinQ and the devices that came before it, are known as Insertable Cardiac Monitors (ICM). They are inserted between the skin and the ribs, in a position where they can record the electrical signals of the heart. The goal of using them is to record the signals from the heart at the time that the patient experiences their syncope. ICMs are usually implanted in hospitals, in specialist rooms.
    The difference between Reveal LinQ and other ICMs is that it is much smaller.( 87% smaller thatn the device it replaced, 1.2cc in volume, its dimensions are 45x7x4 mm).

    This reduction in size has made the insertion of the device into the patient much easier, and as a result a number of hospitals around the country have started inserting them into patients in other rooms rather than specialist rooms thatn can be expensive to use and staff, and the ease of the Reveal LinQ insertion now means there is less need for the additional support of nurses and specialist staff found in specialist rooms.

    The sponsor of this study (Medtronic who manufacture Reveal LinQ ) is looking to provide doctors with clinical evidence that the approach of implanting Reveal LinQ outside of Cardiac Catheter Laboratories is safe and is cost effective.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    15/NW/0746

  • Date of REC Opinion

    29 Oct 2015

  • REC opinion

    Further Information Favourable Opinion