Upgrading Pacemakers for Better Heart Function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Daniel Keene, PhD — Imperial College London
• Study coordinator: Aya Khalil
• Email: a.khalil@imperial.ac.uk
• Phone: 07749576830

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.