Upgrading Pacemakers for Better Heart Function

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Not applicable Interventional Imperial College London · NCT06052475

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

PhaseNot applicable
Study typeInterventional
Enrollment155 (estimated)
Ages18 Years and up
SexAll
SponsorImperial College London Academic / other
Locations12 sites (Cambridge and 11 other locations)
Trial IDNCT06052475 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

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Pacing-Induced CardiomyopathyHeart FailurePhysiological PacingRV PacingBiventricular PacingPacemaker Upgrade
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.