NCT07372651Enrolling by invitation
OPTimising a Screening Program to Detect Pacemaker-associated Heart Failure Using Artificial Intelligence
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 29 Sept 2025
- Start date
- 7 Oct 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- University of Leeds
- Diseases
- Heart failure
- NCT number
- NCT07372651
What you commit to
- Study type: Observational
- Planned participants: 150
- From 7 Oct 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients known to have heart failure
- Patients with cardiac resynchronisation therapy pacemakers/defibrillators.
Lab values
- Patients with any previous measurement of left ventricular ejection fraction \<50%.
Other
- Patients who are unwilling or unable to provide informed consent.
- Patients with conduction system pacemakers.
- Patients with implantable cardioverter defibrillators.
- Patients with leadless pacemakers.
Who the study is looking for
- Adult patients aged ≥18 years
- Patients with existing pacemakers who have a right ventricular pacing burden ≥20%.
- Ability to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiovascular Research Facility, Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.