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Can a simple body scan safely check fluid levels in heart device patients?

NCT ID NCT03045822

Knowledge-focused Sponsor: University Hospital, Clermont-Ferrand 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial asks whether bioimpedance analysis—a quick, painless way to measure body fluid—can be used safely in people with implanted heart devices like pacemakers and defibrillators. Current guidelines warn against it due to possible electromagnetic interference, but this has not been well studied. The study will monitor 200 adults with such devices during and after the scan to see if it disrupts device function.

What this could mean

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

Active substance
Bioimpedance analysis
What this could lead to
If safe, this could allow doctors to use bioimpedance to detect fluid buildup in heart failure patients with implanted devices, improving treatment guidance.
What could go wrong
The trial is small and early, and it only checks for immediate device interference—not long-term safety or clinical benefit. Results may not apply to all device types.

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

200 people

The number who actually took part.

Started

Mar 2014

Finished

Jan 2017

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Patient having a cardiac device with or without cardiac resynchronization * 18 years of age and above * Patients with no pacing-dependent status * Patients who read, understood and signed written informed consent letter Exclusion Criteria: * Patients with acute heart failure * Patients implanted in less than 2 months * Dysfunction of the device in a follow-up visit or in the inclusion visit * Patients with a particular device lead model prone to develop electronical problems such as Sprint Fidelis of Medtronic (Minneapolis, USA) or Riata of St. Jude Medical (St. Paul, USA) * Pregnancy

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As listed by the trial registrant

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

Performing bioimpedance analysis

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France