HIS Alternative II - V1.0

  • Research type

    Research Study

  • Full title

    HIS Alternative II : A Randomised Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block – A Multicentre Randomised Controlled Trial

  • IRAS ID

    235999

  • Contact name

    Daniel Keene

  • Contact email

    d.keene@imperial.ac.uk

  • Sponsor organisation

    Imperial College Healthcare NHS Trust

  • Clinicaltrials.gov Identifier

    NCT05814263

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Cardiac pacing is the treatment of choice for managing patients with bradycardia. Although right ventricular apical pacing is the standard therapy, it is associated with an increased risk of pacing-induced cardiomyopathy and heart failure. Physiological pacing using His bundle pacing and left bundle branch pacing has recently evolved as the preferred alternative pacing option.

    The study will show the feasibility of using direct HIS pacing or Left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block.

    The study's primary endpoint is the echocardiographic response after six months, defined as a relative decrease in left ventricular systolic diameter relative to baseline in a group of patients with conduction disease and heart failure.

    If the study shows that direct HIS pacing or LBB pacing is a possible alternative to biventricular pacing, it may provide evidence alongside other research that could change international guidelines.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    22/LO/0837

  • Date of REC Opinion

    20 Feb 2023

  • REC opinion

    Further Information Favourable Opinion