OPTimising a Screening Program to Detect Pacemaker-associated Heart Failure Using Artificial Intelligence

Enrolling by invitation

Conditions studied: Heart Failure, Pacemaker

In brief

Pacemakers are an effective treatment for slow heart rates which improve symptoms and save lives. However, for some people pacemakers can cause heart failure (HF) because of the unnatural way in which they stimulate heart beats. In several studies conducted in West Yorkshire we showed that \~1/3 of patients with pacemakers have undiagnosed HF. We also showed that where HF is discovered, treating it with safe and inexpensive medications reduces the chances of being admitted to hospital or dying. However, detecting HF requires an echocardiogram (a heart ultrasound scan) which takes \~45 minutes, requires a skilled technician, and costs £120; or, to put it another way \~£540,000 to assess the \~4,500 patients cared for at our hospital. A new approach is needed. We think that using new technologies can improve our ability to screen for HF in people with pacemakers. We will test two approaches. First, we will assess whether a hand-held echocardiogram can measure heart function using artificial intelligence (AI) as accurately as a standard echocardiogram done by a skilled technician. Second, we will assess whether a finger-prick blood test can detect the presence of abnormal function as accurately as a standard echocardiogram.

Key facts

Study ID

NCT07372651

Run by

University of Leeds

People needed

150

Starts

2025-10-07

Expected to finish

2026-09-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients aged ≥18 years
• Patients with existing pacemakers who have a right ventricular pacing burden ≥20%.
• Ability to provide informed consent

You may not qualify if…

• Patients who are unwilling or unable to provide informed consent.
• Patients known to have heart failure
• Patients with any previous measurement of left ventricular ejection fraction <50%.
• Patients with conduction system pacemakers.
• Patients with cardiac resynchronisation therapy pacemakers/defibrillators.
• Patients with implantable cardioverter defibrillators.
• Patients with leadless pacemakers.

Where it is running

• Cardiovascular Research Facility, Leeds General Infirmary — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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