Ablation of low voltage regions in persistent atrial fibrillation

  • Research type

    Research Study

  • Full title

    Catheter ABlation of LOw VOltage regions in the treatment of persistent Atrial Fibrillation (ABLOVO-AF study).

  • IRAS ID

    202816

  • Contact name

    Phang Boon Lim

  • Sponsor organisation

    Imperial College London

  • Clinicaltrials.gov Identifier

    NCT03811938

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofrequency ablation (RFA). This technology works by heating heart muscle inside the heart to break the electrical circuits responsible for the abnormal rhythm. The energy is delivered into the heart with plastic tubes that have metal electrodes, inserted through the groin veins and removed after the procedure. The patient is usually put to sleep during the intervention.
    If the AF has been present for more than seven days but for less than one year it is called persistent, and it can be difficult to treat successfully with the usual methods.
    Goals. Our study will test a new RFA technique to treat patients with persistent AF. This involves identifying areas within the left upper chamber that have a lower electrical voltage than the surrounding heart muscle and applying RFA to the border zones of these areas.
    Methods. We will compare the new technology combined with the usual procedure to the usual procedure alone, randomly assigning patients to either group. The patients will not be aware of the group that they had been assigned to.
    Follow up. We will follow patients up for 12 months with clinic visits and heart rhythm checks.
    Potential benefit. We will assess whether the new technique is more successful at keeping patients free from persistent AF than the usual methods.
    We will perform the study at Imperial College Healthcare NHS Trust, at the Hammersmith Hospital.
    We will be using licensed clinical software from St Jude Medical to guide ablation and a special research software module to analyse data from the heart following ablation. The study will be sponsored by Imperial College Healthcare NHS Trust.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    17/LO/0524

  • Date of REC Opinion

    3 May 2017

  • REC opinion

    Further Information Favourable Opinion