Clinical Trial

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

Study acronym: OPT-AI
Enrolling by Invitation
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Summary
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.
Trial Details
NCT Number NCT07372651
Lead Sponsor University of Leeds
Collaborators: Leeds Hospitals Charity
Conditions Heart Failure, Pacemaker
Enrollment 150 participants
Start Date 2025-10-07
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-28