At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) (device), Continued RV Pacing (Right Ventricular Pacing) (device)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) — device: The approach for physiological pacing upgrade will be either His bundle pacing or left bundle pacing at the operator's discretion. · Continued RV Pacing (Right Ventricular Pacing) — device: Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 155
- Started
- 2023-09-04
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for pacing-induced cardiomyopathy
- • NA - 155 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pacing-induced cardiomyopathy
Where?
- • Cambridge - Royal Papworth Hospital
- • Chichester - St. Richard's Hospital - University Hospitals Sussex
- • Coventry - University Hospitals Coventry and Warwickshire NHS Trust,
- • Croydon - Croydon University Hospital - Croydon Health Services
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Who cannot take part
- ✗Those unable to provide agreement to take part
- ✗Patients under age 18
- ✗Pregnant women
See the full criteria
Where Is This Study? (12 UK sites)
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
Hammersmith Hospital
London, 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
How to Get in Touch
Aya Khalil
Sponsor contactCONTACT
Nandita Kaza, MRCP
Sponsor contactCONTACT