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CardioMEMS Outside US Study

  • Research type

    Research Study

  • Full title

    CardioMEMS Heart Failure System "Outside US" Post-Approval Study

  • IRAS ID

    219676

  • Contact name

    Susan Neville

  • Contact email

    sneville@sjm.com

  • Sponsor organisation

    St Jude Medical

  • Clinicaltrials.gov Identifier

    NCT02954341

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Patients being treated for heart failure may need to be admitted to hospital for treatment of symptoms. It is known that the blood pressure in the lung arteries increases a few days before symptoms cause hospitalisation. In this study a pressure sensor (CardioMEMS) is implanted in the lung artery. It measures pressure and transmits the data on a daily basis to the hospital. The hospital staff can monitor the pressure and if it starts to rise they can modify the patients treatment before the pressure gets too high and causes hospitalisation. In addition, they can modify treatment to maintain the pressure in the lung arteries at a 'target' range that has been shown in a previous randomised trial in the USA to reduce the risk of the need for hospitalisation for symptom control (The Champion Study).
    Study visits are for screening, sensor implant, 1 month, 6 months, 12 months, 18 months and 24 months.
    About 150 patients will be recruited at 10 centres in the UK.
    The primary effectiveness endpoint will compare the annualized HF hospitalization rate at 1 year in the study to the HF hospitalization rate in the year prior to enrolment.
    Primary safety endpoints will be evaluated at 2 years:
    1) Freedom from device/system related complications
    2) Freedom from pressure sensor failure

    This study will help confirm if the results of the previous randomised trial in the USA appear generalisable to the UK NHS setting.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    17/LO/0041

  • Date of REC Opinion

    27 Feb 2017

  • REC opinion

    Further Information Favourable Opinion