Optimized MultiSite Pacing (MSP) Vector Study

  • Research type

    Research Study

  • Full title

    Multimodality assessment of acute and long term response to optimised Multi-Site pacing cardiac resynchronisation (MSP CRT) devices compared to biventricular (BiV) CRT, in patients with heart failure.

  • IRAS ID

    246859

  • Contact name

    Anthony Wai-Cheong Chow

  • Contact email

    anthony.chow@bartshealth.nhs.uk

  • Sponsor organisation

    Barts Health NHS Trust

  • Clinicaltrials.gov Identifier

    NCT03938090

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    The objective of this clinical investigation is to evaluate the clinical benefits of optimisation of multi-site pacing (MSP) cardiac resynchronisation therapy (CRT)pacemakers. These are advanced pacemakers used to treat patients with weak heart muscle pumps or "heart failure"; they pace the heart muscle with electrical impulses from several points of the heart to coordinate the heart muscle's contraction. Optimisation of the programming settings will occur at the time of device implantation procedure using a pressure wire study (real-time measurements of the heart's pump performance) of the left ventricle (the main pump of the heart). Once the best pacing settings have been established and recorded, patients will be randomized to either optimised MSP CRT (best pacing settings) or conventional biventricular (BiV) CRT (standard settings) at 1 month. They will then undergo follow up at 3 months and 6 month to assess the effect of the CRT device on symptoms and their heart pump function. At 3 months, cross-over will occur and the programming settings of the device will be changed to the alternate programming group (MSP CRT or BiV CRT). Cross-over of each patient to alternate programming settings allows patients to act as their own control, allowing the impact of different CRT programming settings to be fully assessed.
    The aim of this study is to assess the impact of different CRT programming settings on patient outcomes and heart function; in particular how best to use MSP CRT therapy. We also aim to establish a methodology to improve the performance of CRT devices through optimal patient-specific programming.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    19/LO/1029

  • Date of REC Opinion

    7 Aug 2019

  • REC opinion

    Further Information Favourable Opinion