Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy. However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians 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 from the traditional RV pacing approach. In this crossover trial, participants will be upgraded to a physiological pacing strategy. After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing). They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods. Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire. The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
155
The approach for physiological pacing upgrade will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Royal Papworth Hospital
Cambridge, United Kingdom
RECRUITINGSt. Richard's Hospital - University Hospitals Sussex
Chichester, United Kingdom
RECRUITINGUniversity Hospitals Coventry and Warwickshire NHS Trust,
Coventry, United Kingdom
RECRUITINGCroydon University Hospital - Croydon Health Services
Croydon, United Kingdom
RECRUITINGGlenfield Hospital
Leicester, United Kingdom
RECRUITINGHammersmith Hospital
London, United Kingdom
RECRUITINGKing's College Hospital
London, United Kingdom
RECRUITINGSt Bartholomew's Hospital - Barts Health NHS Trust
London, United Kingdom
RECRUITINGOxford University Hospitals
Oxford, United Kingdom
RECRUITINGUniversity Hospitals Southampton
Southampton, United Kingdom
RECRUITING...and 2 more locations
SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary
Time frame: From date of baseline, until end of trial follow-up at fourteen months post-baseline
Left ventricular ejection fraction
(% ejection fraction)
Time frame: From date of baseline, until end of trial follow-up at fourteen months
Left ventricular end systolic volume
(millilitres)
Time frame: From date of baseline, until end of trial follow-up at fourteen months
Minnesota Living with Heart Failure Questionnaire
Time frame: From date of baseline, until end of trial follow-up at fourteen months
Six-minute walk test
Measured in distance in metres
Time frame: From date of baseline, until end of trial follow-up at fourteen months
Atrial fibrillation
(atrial fibrillation percentage burden as measured by pacemaker device - %)
Time frame: From date of baseline, until end of trial follow-up at fourteen months
Patient preference based on blinded symptomatic preference
Time frame: At 2 months following baseline and 14 months following baseline visit
EQ-5D Questionnaire
EQ-5D is the name of the instrument and is not an acronym. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ 'visual analogue scale' (EQ VAS). The descriptive system is made up of 5 sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative (numerical) measure of health outcome that reflect the patient's own judgement. A high score on the VAS means a better outcome. A low score on the VAS means a worse outcome.
Time frame: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit
Patient symptoms assessed on a scale of 0-100 monthly
This questionnaire will be sent to participants on a monthly basis for the duration of the study
Time frame: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit
Safety endpoints
Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
Time frame: From device implant date, assessed up to 15 months at the end of the trial (including a one-month run-in period post-procedure prior to the first baseline visit)
SF-36 (Short Form 36 Health Survey Questionnaire) Overall Score
Time frame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
SF-36 (Short Form 36 Health Survey Questionnaire) Individual Component Scores
Time frame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
BNP (B-type natriuretic peptide)
B-type natriuretic peptide blood test
Time frame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
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