Upgrading Pacemakers for Better Heart Function
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
This study tests if upgrading from a traditional pacemaker to a newer type can help people with heart problems feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 12 sites (Cambridge and 11 other locations) |
| Trial ID | NCT06052475 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether patients with traditional right ventricular (RV) pacemakers and impaired heart function can improve their symptoms and quality of life by upgrading to a modern physiological pacing strategy. Participants will undergo a crossover design where they will initially continue with RV pacing before being randomized to either continue RV pacing or switch to physiological pacing for one-month periods. The study aims to assess the impact of this upgrade on heart function and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with RV pacemakers, left ventricular ejection fraction (LVEF) between 35-50%, and a high burden of right ventricular pacing.
Not a fit: Patients who are unable to provide informed consent, those under 18, or pregnant women will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and heart function for patients with pacing-induced cardiomyopathy.
How similar studies have performed: Other studies have shown promising results with physiological pacing approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (\>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and: 1. EF reduced by \>5% of increase in LVESV by 10ml since implant 2. NT-proBNP \>250ng/L in sinus rhythm 3. NT-proBNP \> 750 Ng/L if AF 4. Left atrial volume index \> 30ml/m2 5. Regular loop diuretics prescribed 6. Decline in daily patient activity by \>1 hour per day since implant 7. Decrease in device measured thoracic impedance 8. Patient reported decline in functional class or exercise tolerance Exclusion Criteria: * Those unable to provide informed consent * Patients under age 18 * Pregnant women
Where this trial is running
Cambridge and 11 other locations
- Royal Papworth Hospital — Cambridge, United Kingdom (Recruiting)
- St. Richard's Hospital - University Hospitals Sussex — Chichester, United Kingdom (Recruiting)
- University Hospitals Coventry and Warwickshire NHS Trust, — Coventry, United Kingdom (Recruiting)
- Croydon University Hospital - Croydon Health Services — Croydon, United Kingdom (Recruiting)
- Glenfield Hospital — Leicester, United Kingdom (Recruiting)
- Hammersmith Hospital — London, United Kingdom (Recruiting)
- King's College Hospital — London, United Kingdom (Recruiting)
- St Bartholomew's Hospital - Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Oxford University Hospitals — Oxford, United Kingdom (Recruiting)
- University Hospitals Southampton — Southampton, United Kingdom (Recruiting)
- Great Western Hospitals — Swindon, United Kingdom (Recruiting)
- Worthing Hospital - University Hospitals Sussex — Worthing, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Daniel Keene, PhD — Imperial College London
- Study coordinator: Aya Khalil
- Email: a.khalil@imperial.ac.uk
- Phone: 07749576830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.