AFFECT study

  • Research type

    Research Study

  • Full title

    AFFECT study: Predicting the return of atrial fibrillation (AF) following electrical cardioversion treatment. A project to identify clinical and electrocardiogram (ECG) predictors of atrial fibrillation (AF) recurrence following successful electrical cardioversion (ECV) for persistent AF - a pilot study.

  • IRAS ID

    260488

  • Contact name

    STEPHEN J. LESLIE

  • Contact email

    stephen.leslie@nhs.net

  • Sponsor organisation

    NHS Highland

  • Clinicaltrials.gov Identifier

    Highland 1620, SReDa ID no.

  • Duration of Study in the UK

    0 years, 6 months, 7 days

  • Research summary

    This is a study involving patients with persistent atrial fibrillation (AF) having electrical cardioversion (ECV) to restore sinus rhythm (SR). The aim of the study is to identify clinical and electrocardiogram (ECG) derived features with predictive value in identifying patients at risk of AF recurrence versus SR maintenance after initially successful ECV.
    Atrial Fibrillation (AF) is the most common heart rhythm disorder, causing symptoms such as palpitations, breathlessness and reduced exercise tolerance, and intra cardiac thrombi which increase the risk of embolic events such as stroke five-fold. ECV is a standard procedure to restore sinus rhythm (SR), and is an essential part of rhythm control strategy (+/- pharmacological agents) for the treatment of AF, despite not offering prognostic benefit over rate control (accepting permanent AF) in terms of mortality. However, AF relapse following ECV is associated with increased risk of mortality, and long-term maintenance of sinus rhythm difficult, making patient selection important. Treatment decisions for persistent AF are based on clinical symptoms and 'perceived likelihood' of successful cardioversion, yet the long-term success rate remains low.
    Patients will be asked to wear an 'ambulatory holter' ECG monitor immediately before, and for 24 hours after their procedure if it has been initially successful.
    The study will collect ECG telemetry data and analyse it for any predictive features for AF recurrence or SR maintenance. The anonymised raw data will undergo statistical analysis.
    The results of the study may be used to inform clinical decision making. The results will be presented locally and may be published in an academic journal.

  • REC name

    Wales REC 7

  • REC reference

    20/WA/0126

  • Date of REC Opinion

    28 Aug 2020

  • REC opinion

    Further Information Favourable Opinion