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AI-Powered PET scans could revolutionize heart device infection diagnosis

NCT ID NCT07454096

Diagnosis Sponsor: Fundacion Clinic per a la Recerca Biomédica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study explores whether artificial intelligence can make PET scans better at detecting and monitoring infections in implanted heart devices like pacemakers and artificial valves. Researchers will compare AI analysis of scans to standard visual interpretation in 200 patients. If it works, this could lead to faster, more accurate diagnoses and better tracking of treatment response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FDG-PET/CT imaging
What this could lead to
If successful, this could lead to a more accurate, non-invasive way to diagnose and monitor heart device infections, potentially reducing unnecessary treatments.
What could go wrong
This is a single-center, early-phase study with only 200 participants. The AI-based method may not prove more accurate than current approaches, and results may not apply to all patients or devices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 84 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years. * Implanted cardiovascular device (prosthetic valve, TAVI, CIED, vascular graft/endograft). * For infected cohorts: patients studied by FDG-PET with definitive diagnosis of CVDI based on multidisciplinary evaluation. * For control group: no clinical suspicion of infection at time of inclusion. * Written Informed consent provided (prospective cohort and control group). * Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence (only if refraining from heterosexual intercourse during the period of twelve months of duration of the study). Exclusion Criteria: * Inability to undergo FDG-PET due to contraindications (e.g., allergies, claustrophobia). * Pregnancy or breastfeeding. * Incomplete clinical data or lack of access to imaging studies. * Refusal or withdrawal of informed consent (for control and prospective cohort).

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Conditions

The condition(s) this trial relates to.

heart disorder prosthesis-related infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac disease Device related infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clinic Barcelona

    Barcelona, Barcelona, 08036, Spain

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