Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
- Conditions
- Pacing-Induced CardiomyopathyHeart Failure
- Interventions
- Device: Continued RV Pacing (Right Ventricular Pacing)Device: Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)
- Registration Number
- NCT06052475
- Lead Sponsor
- Imperial College London
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 155
Not provided
- Those unable to provide informed consent
- Patients under age 18
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Right Ventricular Pacing Continued RV Pacing (Right Ventricular Pacing) Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice) Physiological Pacing (Conduction System Pacing or Biventricular Pacing) Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) The approach for physiological pacing 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.
- Primary Outcome Measures
Name Time Method SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary From date of baseline, until end of trial follow-up at fourteen months post-baseline
- Secondary Outcome Measures
Name Time Method BNP (B-type natriuretic peptide) From date of baseline, until end of trial follow-up at fourteen months post baseline visit B-type natriuretic peptide blood test
Minnesota Living with Heart Failure Questionnaire From date of baseline, until end of trial follow-up at fourteen months Six-minute walk test From date of baseline, until end of trial follow-up at fourteen months Measured in distance in metres
Atrial fibrillation From date of baseline, until end of trial follow-up at fourteen months (atrial fibrillation percentage burden as measured by pacemaker device - %)
Left ventricular ejection fraction From date of baseline, until end of trial follow-up at fourteen months (% ejection fraction)
Left ventricular end systolic volume From date of baseline, until end of trial follow-up at fourteen months (millilitres)
Safety endpoints 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) Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
SF-36 (Short Form 36 Health Survey Questionnaire) Overall Score From date of baseline, until end of trial follow-up at fourteen months post baseline visit Patient preference based on blinded symptomatic preference At 2 months following baseline and 14 months following baseline visit EQ-5D Questionnaire From date of baseline, until end of trial follow-up at fourteen months post-baseline visit 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.Patient symptoms assessed on a scale of 0-100 monthly From date of baseline, until end of trial follow-up at fourteen months post-baseline visit This questionnaire will be sent to participants on a monthly basis for the duration of the study
SF-36 (Short Form 36 Health Survey Questionnaire) Individual Component Scores From date of baseline, until end of trial follow-up at fourteen months post baseline visit
Trial Locations
- Locations (12)
Royal Papworth Hospital
🇬🇧Cambridge, United Kingdom
St. Richard's Hospital - University Hospitals Sussex
🇬🇧Chichester, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust,
🇬🇧Coventry, United Kingdom
Croydon University Hospital - Croydon Health Services
🇬🇧Croydon, United Kingdom
Glenfield Hospital
🇬🇧Leicester, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
St Bartholomew's Hospital - Barts Health NHS Trust
🇬🇧London, United Kingdom
Oxford University Hospitals
🇬🇧Oxford, United Kingdom
University Hospitals Southampton
🇬🇧Southampton, United Kingdom
Great Western Hospitals
🇬🇧Swindon, United Kingdom
Worthing Hospital - University Hospitals Sussex
🇬🇧Worthing, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom