Could a smartphone app help your heart and your memory after a procedure for AFib?
NCT ID NCT07119528
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a mobile app that provides education, medication reminders, and risk factor management can help people with atrial fibrillation stay free of heart rhythm problems after a new type of heart procedure called FARAPULSE pulse field ablation. The study will include 500 adults who are having this procedure for the first time. Half will use the app, and half will not. Researchers will also check if the procedure and the app help protect thinking and memory.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mobile application-based integrated care program
- What this could lead to
- If it works, this could show that a simple app helps people with atrial fibrillation stay free of heart rhythm problems and may even protect their memory and thinking after a heart procedure.
- What could go wrong
- This is a relatively early study (Phase NA) with 500 participants. The app is an add-on, so any benefit may be small. Also, the study relies on people using the app consistently, which may not happen in real life.
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 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 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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19 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: 1. patients who were treated with the FARAPULSE™ PFA for AF as a de novo procedure 2. Subjects who are willing and capable of providing informed consent 3. Subjects who are willing and capable of participating in App-base integrated care Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law Exclusion Criteria: 1. Subjects with a current interatrial baffle or patch 2. Subjects with a known or suspected atrial myxoma 3. Subjects with myocardial infarction within 14 days prior to enrollment 4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA) 5. Subjects who do not tolerate anticoagulation therapy 6. Subjects with an active systemic infection \* 7. Subjects with a presence of atrial known thrombus \* 8. Subjects with a known inability to obtain vascular access 9. Subjects who are pregnant or planning to be pregnant 10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes 11. Subjects with any prosthetic heart valve, ring, or repair including balloon aortic valvuloplasty 12. Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgment, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure/unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels) 13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion 14. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.
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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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Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
RECRUITINGSeoul, 03722, South Korea
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