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Research type
Research Study
Full title
Physiological versus Right ventricular pacing outcome trial for bradycardia treatment upgrades
IRAS ID
323165
Contact name
Daniel Keene
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
We may be able to rescue a generation of patients who are being abandoned to progressive injury to their heart from previous-generation pacemakers. This is because there is no randomised evidence to show that they would fare better with upgrade to modern pacing strategies. Today, if patients who require pacemakers for slow heart rates have even mildly impaired heart function, they receive modern pacing strategies (via His bundle, left bundle or biventricular pacing) rather than traditional right ventricular (RV pacing. RV pacing activates the heart’s main pumping chambers (ventricles) in a slow, abnormal sequence. Modern pacing produces efficient activation via the heart’s natural conduction system.
Trials in patients having first-time implants show that even when heart function is only mildly impaired, modern pacing avoids damaging effects of RV pacing, preventing symptom deterioration and death.However, once a traditional pacemaker is implanted, development of impaired heart function does not prompt us to upgrade the device. Even at the end of battery life, we simply replace it like-for-like.
This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy.
Patients will document symptoms weekly on a smartphone app/computer. At the end of each month, they will have measurements of heart function, a walking test and quality-of-life questionnaires. After 2 months, they review their own recorded symptoms and decide if one month was clearly better.
Patients will then have two 6-month periods in each strategy, document their symptoms and review them at the end. Again, they will have tests after each 6-month period.
We hypothesise that patients will prefer modern pacing strategies and that these will improve their quality of life.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
23/NW/0144
Date of REC Opinion
6 Jul 2023
REC opinion
Further Information Favourable Opinion