Can your blood pressure cuff spot a hidden heart problem?
NCT ID NCT04464499
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a smart blood pressure cuff called the Withings BPM Core can accurately detect atrial fibrillation, a common heart rhythm problem. Researchers will compare the device's single-lead ECG readings to a standard 12-lead ECG in 160 adults. If it works well, it could offer a convenient way for people to screen for AFib at home.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Withings BPM Core (smart blood pressure cuff with ECG)
- What this could lead to
- If successful, this device could help people easily check for atrial fibrillation at home, leading to earlier detection and treatment.
- What could go wrong
- This is a validation study, not a treatment trial. The device may not be as accurate as a standard ECG, and results may not apply to all users.
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.
- Participants
-
About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2020
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
in and out patients from cardiology services
- Ages
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18 to 100 years
- Sex
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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 Hide 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: * male or female who are 18 years or older * Subject who signed the written informed consent form, * Able to communicate effectively with and follow instructions from the study staff * Person with an arm circumference between 22 and 42 cm Exclusion Criteria: * Vulnerable subject with regard to regulations * Pregnant, parturient or breastfeeding woman, * Subject who is deprived of liberty by judicial, medical or administrative decision, * Underage subject, * Legally protected subject, or subject who is unable to sign the written informed consent form, * Subject who is not beneficiary or not affiliated to a social security scheme, * Subject within several of the above categories, * Subject who refused to participate in the study, * Subject in linguistic or psychic incapacity to sign a written informed consent form, * Subject in physical incapacity to wear a blood pressure monitor * Subject with electrical stimulation by pacemaker * Significant tremor that prevents subject from being able to hold still * Known sensitivity to medical adhesives, isopropyl alcohol, or ECG electrodes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ICPC Floréale
Bagnolet, 93170, France
-
ICPC Turin
Paris, 75004, France
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