PROTECT-HF

• Research type

  Research Study

• Full title

  PROTECT-HF: Physiological Vs Right ventricular pacing Outcome Trial Evaluated for bradyCardia Treatment

• IRAS ID

  312355

• Contact name

  Daniel Keene

• Contact email

  d.keene@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Clinicaltrials.gov Identifier

  NCT05815745

• Duration of Study in the UK

  6 years, 3 months, 31 days

• Research summary

  The PROTECT-HF trial, funded by the British Heart Foundation, will compare two different pacing approaches for treating patients with slow heart rates. In it we will compare the standard approach for pacing, right ventricular pacing, with a new form of pacing, physiological pacing. With right ventricular pacing the pacemaker lead is positioned on the heart muscle in the right ventricle (the chamber of the heart which pumps blood to the lungs). This method is very effective at treating slow heart rates, however produces an abnormal sequence in the way the ventricles (the main pumping chambers of the heart) are activated. This abnormal activation is less efficient and can lead to impairment in heart function.

  During physiological pacing, the pacemaker lead is positioned on the heart’s natural electrical conduction system allowing a normal efficient pattern of ventricular activation.
  The trial will establish whether preserving the heart’s normal activation sequence using physiological pacing results in a reduction in heart failure and death. This study is important as it will allow us to know what the best pacing approach is for people slow heart rates.

  Protect-HF is a randomised controlled trial (RCT) which means people will be randomly allocated to receive either right ventricular pacing or physiological pacing. The randomisation is to make sure characteristics of people included in treatment groups are the same. This is important as it makes sure that any differences in the outcomes between the groups is only due to differences in the treatment they received.

  The trial will allow us to establish whether physiological pacing results in
  better long-term outcomes compared to right ventricular pacing. Until we formally test this new technique in a RCT, we cannot be sure whether this treatment results in better outcomes.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  23/NE/0012

• Date of REC Opinion

  30 Mar 2023

• REC opinion

  Further Information Favourable Opinion