Smartwatches may help doctors decide when to treat AF, new trial aims to prove it
NCT ID NCT07512037
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial will enroll about 3,200 people with paroxysmal atrial fibrillation (AF) to see if using a smartwatch to continuously track AF burden can guide earlier and better treatment. Participants will be monitored with a wearable device, and if their AF burden is high, doctors will step up therapy—like adjusting medications or considering a procedure. The goal is to reduce serious events such as stroke, heart failure, and hospitalizations over one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 5D-AF burden-guided active management (behavioral intervention using wearable PPG monitoring and stepwise rhythm control)
- What this could lead to
- If successful, this could show that continuous wearable monitoring helps doctors decide when to start or adjust treatment, potentially reducing serious AF complications like stroke and heart failure.
- What could go wrong
- This trial is not yet recruiting and is early-stage for this specific monitoring model. The approach may not reduce adverse events more than standard care, and results may not apply to all AF patients.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 3,194 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Inpatients ≥18 years of age at admission; * Paroxysmal atrial fibrillation was diagnosed; * Own a smart phone and a smart watch and be able to operate them basically; * Before being enrolled, the average daily atrial fibrillation burden was calculated to be ≥ 4.59% based on monitoring through an intelligent wristwatch for at least 3 days; * The treatment status meets any of the following conditions: 1. If anticoagulation therapy is being administered, the treatment plan must be stable for at least 4 weeks; 2. If heart rate or rhythm control medications are being used, the treatment plan must be stable for at least 4 weeks; 3. Or no specific rhythm control treatment for atrial fibrillation is being received; * Sign the informed consent form Exclusion Criteria: * Has an implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device. * There may be skin diseases, limb deformities or allergies that prevent the proper wearing of wearable devices on the upper limbs. * Having active mental disorders or cognitive impairments, as well as other conditions that result in lack of or restricted ability to act, and which, in the judgment of the researchers, make it impossible for the subject to comply with the trial protocol. * During pregnancy, lactation, or planning to become pregnant during the trial period. * At the same time, participate in other clinical trials that may interfere with the results of this study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sixth Medical Center of Chinese PLA General Hospital
Beijing, China
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Other studies related to the condition(s) this trial covers.
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