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RESHAPE-HF2 v. 3.4 dated 15.03.2017

  • Research type

    Research Study

  • Full title

    RANDOMISED INVESTIGATION OF THE MITRACLIP DEVICE IN HEART FAILURE: 2ND TRIAL IN PATIENTS WITH CLINICALLY SIGNIFICANT FUNCTIONAL MITRAL REGURGITATION

  • IRAS ID

    220456

  • Contact name

    Anker Stefan

  • Contact email

    s.anker@cachexia.de

  • Sponsor organisation

    University of Gottingen

  • Clinicaltrials.gov Identifier

    NCT02444338

  • Duration of Study in the UK

    3 years, 3 months, 10 days

  • Research summary

    Patients who have a heart muscle that does not pump as well as it should are said to have heart failure. The hearts of patients with heart failure are often enlarged. One of the detrimental effects of having a heart that is too large is that one of the heart valves, the mitral valve, sometimes becomes leaky. A new technique using a device called Mitraclip can make this valve less leaky by pinching or clipping the tips of the valve together. This device is inserted by passing a tube from the groin through the veins into the heart ie the procedure does not involve open heart surgery. In the current trial patients will be looked after as well as possible with half undergoing the new procedure and half remaining as they are.

  • REC name

    West of Scotland REC 4

  • REC reference

    17/WS/0187

  • Date of REC Opinion

    13 Oct 2017

  • REC opinion

    Further Information Favourable Opinion