Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA SystemNCT07119528
Application-Based Integrated Care in Patients After Pulse Field Ablation
A study testing AF application enhancing AF education and AF application without enhancing AF education and drug adhrence in people with Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, run by Yonsei University at 1 site in South Korea.
Trial summary
"Atrial fibrillation (AF) is known as the most common sustained arrhythmia observed in clinical situation. Pulse Field Ablation (PFA) is a recently introduced, effective atrial fibrillation (AF) ablation modality. PFA is safe for treating patients with AF. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System
- What is being tested?
- AF application enhancing AF education and AF application without enhancing AF education and drug adhrence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who were treated with the FARAPULSE™ PFA for AF as a de novo procedure
- Subjects who are willing and capable of providing informed consent
- 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
Who cannot join
- Subjects with a current interatrial baffle or patch
- Subjects with a known or suspected atrial myxoma
- Subjects with myocardial infarction within 14 days prior to enrollment
- Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
- Subjects who do not tolerate anticoagulation therapy
- Subjects with an active systemic infection *
Show all 14Show fewer
- Subjects with a presence of atrial known thrombus *
- Subjects with a known inability to obtain vascular access
- Subjects who are pregnant or planning to be pregnant
- Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
- Subjects with any prosthetic heart valve, ring, or repair including balloon aortic valvuloplasty
- 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)
- Subjects with a life expectancy of ≤ 1 year per investigator's opinion
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Boyoung Joung, M.D., Ph.D., +82-2228-8447, CBY690@yuhs.ac
About this study
Official title: Application-Based Integrated Care Approach for Enhancing the Effect of FARAPULSE™ Pulse Field Ablation in Patients With Atrial Fibrillation: Randomized Control Trial
"Atrial fibrillation (AF) is known as the most common sustained arrhythmia observed in clinical situation. Pulse Field Ablation (PFA) is a recently introduced, effective atrial fibrillation (AF) ablation modality. PFA is safe for treating patients with AF. The "MANIFEST-17K" international study showed important safety outcomes in 17,642 AF patients undergoing post-approval PFA, including no significant risk of esophageal damage, with PFA. PFA provides an appealing alternative to cryoablation and radiofrequency ablation, which often cause damage to non-targeted tissues, particularly the esophagus and phrenic nerve.
An integrated care approach including risk factor management might be of benefit to the clinical outcomes of patients with AF. A mobile application-based integrated care approach is also relatively new and can reduce the burden of physicians and nurses. Recent studies showed that an integrated care approach to holistic AF care can improve the outcome of population-based studies. However, the effect of the mobile application-based integrated care approach has not been evaluated in ablation patients.
Read more
Dementia, a decline in memory and other cognitive functions leading to disability in daily function is a common and feared geriatric condition. Although catheter ablation is one of the main treatments for AF, whether it can improve cognitive function in patients with AF remains unclear. Multiple observational trials have shown that catheter ablation is also associated with a lower risk of cognitive decline, dementia, and improved cognitive testing that can be explained through a variety of pathways.
FARAPULSE™ PFA is becoming a widely used ablation technique in AF patients, and knowing the effect of an application-based integrated care approach after AF PFA ablation, and the change in cognitive function is novel. The hypothesis of the study is that AF freedom will be improved by using an application-based integrated care approach in AF patients after the FARAPULSE™ PFA. Another hypothesis is that because of the short procedure time of PFA, the cognitive function will be improved after PFA, and further improved using an application-based integrated care approach.
Read the detailed description
This is a prospective, randomized, multicenter study including about 10 hospitals in South Korea. Among subjects treated with the FARAPULSE™ PFA system, those signing the informed consent form will be included in the study. Patients will be randomly assigned in a 1:1 ratio, with the use of a Web-based randomization system, to receive either Application-based integrated care (AF-App group, n=250) or locally available care (no-AF-App group, n=250). They will be followed by 3 Months, 6 Months, and 12 Months. The primary endpoint includes AF freedom (the "ablation and drug-free").
The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires.
Follow-up assessments will be conducted upto 12 months after enrollment. The anticipated enrollment period is 2 years, with a follow-up duration of one year.
Participants will have voluntary access to educational materials in the app. Medication adherence will be encouraged through reminder alarms, while other educational components will not have specific evaluation methods. The study investigator is responsible for developing the medication adherence education app. The app's content is currently being finalized, and development will be completed using research funding after study approval.
Randomization will be conducted using an Excel macro function, assigning participants in a 1:1 ratio. The randomization process will be uploaded to iCReaT, an electronic case report form (eCRF) system, allowing verification at the time of participant registration.
Primary Outcome: AF freedom at 12 months post-index procedure. (the "ablation and drug-free"). AF Freedom defined as: Freedom from recurrence of individual types of AF, or new AFLs or Ats between 3 month and 12-Month follow-up requiring additional ablation or AADs.
Secondary Outcomes: AF burden: average AF amount per day measured using 1-, 3- or 7-day Holter monitoring at baseline (before ablation), 6, 12 months after PFA.
- Being tested
- AF application enhancing AF education, AF application without enhancing AF education and drug adhrence
- Keywords
- Atrial fibrillation, Pulse field ablation, Integrated care, Application
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF application enhancing AF educationOther
This group will use AF-application. The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires.
AF application without enhancing AF education and drug adhrenceOther
This group will use AF-application. However, this application will not contain materials enhancing AF education and adherence.
| Study group | Role | What they receive |
|---|---|---|
| App education group | Experimental | Not described Receives: Other: AF application enhancing AF education |
| No-App education group | Experimental | Not described Receives: Other: AF application without enhancing AF education and drug adhrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF freedom at 12 months post-index procedure.
Freedom from recurrence of individual types of AF, or new AFLs or Ats between 3 month and 12-Month follow-up requiring additional ablation or AADs
Measured: average AF amount per day measured using 1-, 3- or 7-day Holter monitoring at baseline (before ablation), 6, 12 months after PFA.
Secondary outcomes (7)
Atrial fibrillation (AF) burden
Atrial burden refers to the proportion of time a patient experiences atrial fibrillation (AF) during a defined observation period, often expressed as a percentage. It's a crucial quantitative measure that helps in assessing stroke risk, the efficacy of antiarrhythmic treatments, and the need for oral anticoagulation. AF burden is measured using Holter monitoring (24 to 72 hours or sometimes upto 7 days) at baseline (before ablation), 6, and 12 months after PFA.
Measured: upto 12 month follow-up
time to stroke (ischemic and hemorrhagic)
Secondary end points assessed time to stroke (ischemic and hemorrhagic), measured as the time from randomization to the first occurrence of either of these events.
Measured: upto 12 month follow-up
time to transient ischemic attack (TIA)
Secondary end points assessed time to transient ischemic attack (TIA), measured as the time from randomization to the first occurrence of either of these events.
Measured: upto 12 month follow-up
time to systemic embolism
Secondary end points assessed time to systemic embolism, measured as the time from randomization to the first occurrence of either of these events.
Measured: upto 12 month follow-up
time to major bleeding
Secondary end points assessed time to major bleeding, measured as the time from randomization to the first occurrence of either of these events. Major bleeding was defined according to the criteria of International Society on Thrombosis and Haemostasis (ISTH) as clinically overt bleeding which was fatal or associated with any of the following: (a) a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells, (b) involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal).
Measured: upto 12 month follow-up
time to clinically relevant non-major bleeding
Secondary end points assessed time to clinically relevant non-major bleeding, measured as the time from randomization to the first occurrence of either of these events. Clinically relevant non-major bleeding define a bleeding event that is neither a major bleed as defined by the ISTH 1 nor a non-clinically consequential minor bleeding event.
Measured: upto 12 month follow-up
time to hospitalization events
Secondary end points assessed time to hospitalization events, measured as the time from randomization to the first occurrence of either of these events.
Measured: upto 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start21 Jul 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA SystemStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119528
- Sponsor's protocol ID
- 4-2025-0698
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application-Based Integrated Care Approach for Enhancing the Effect of FARAPULSE™ Pulse Field Ablation in Patients With Atrial Fibrillation: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07119528
- Acronym / sponsor ID
- 4-2025-0698
- Keywords
- Atrial fibrillation, Pulse field ablation, Integrated care, Application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Atrial fibrillation (AF) is known as the most common sustained arrhythmia observed in clinical situation. Pulse Field Ablation (PFA) is a recently introduced, effective atrial fibrillation (AF) ablation modality. PFA is safe for treating patients with AF. The "MANIFEST-17K" international study showed important safety outcomes in 17,642 AF patients undergoing post-approval PFA, including no significant risk of esophageal damage, with PFA. PFA provides an appealing alternative to cryoablation and radiofrequency ablation, which often cause damage to non-targeted tissues, particularly the esophagus and phrenic nerve.
An integrated care approach including risk factor management might be of benefit to the clinical outcomes of patients with AF. A mobile application-based integrated care approach is also relatively new and can reduce the burden of physicians and nurses. Recent studies showed that an integrated care approach to holistic AF care can improve the outcome of population-based studies. However, the effect of the mobile application-based integrated care approach has not been evaluated in ablation patients.
Dementia, a decline in memory and other cognitive functions leading to disability in daily function is a common and feared geriatric condition. Although catheter ablation is one of the main treatments for AF, whether it can improve cognitive function in patients with AF remains unclear. Multiple observational trials have shown that catheter ablation is also associated with a lower risk of cognitive decline, dementia, and improved cognitive testing that can be explained through a variety of pathways.
FARAPULSE™ PFA is becoming a widely used ablation technique in AF patients, and knowing the effect of an application-based integrated care approach after AF PFA ablation, and the change in cognitive function is novel. The hypothesis of the study is that AF freedom will be improved by using an application-based integrated care approach in AF patients after the FARAPULSE™ PFA. Another hypothesis is that because of the short procedure time of PFA, the cognitive function will be improved after PFA, and further improved using an application-based integrated care approach.
Detailed description
This is a prospective, randomized, multicenter study including about 10 hospitals in South Korea. Among subjects treated with the FARAPULSE™ PFA system, those signing the informed consent form will be included in the study. Patients will be randomly assigned in a 1:1 ratio, with the use of a Web-based randomization system, to receive either Application-based integrated care (AF-App group, n=250) or locally available care (no-AF-App group, n=250). They will be followed by 3 Months, 6 Months, and 12 Months. The primary endpoint includes AF freedom (the "ablation and drug-free").
The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires.
Follow-up assessments will be conducted upto 12 months after enrollment. The anticipated enrollment period is 2 years, with a follow-up duration of one year.
Participants will have voluntary access to educational materials in the app. Medication adherence will be encouraged through reminder alarms, while other educational components will not have specific evaluation methods. The study investigator is responsible for developing the medication adherence education app. The app's content is currently being finalized, and development will be completed using research funding after study approval.
Randomization will be conducted using an Excel macro function, assigning participants in a 1:1 ratio. The randomization process will be uploaded to iCReaT, an electronic case report form (eCRF) system, allowing verification at the time of participant registration.
Primary Outcome: AF freedom at 12 months post-index procedure. (the "ablation and drug-free"). AF Freedom defined as: Freedom from recurrence of individual types of AF, or new AFLs or Ats between 3 month and 12-Month follow-up requiring additional ablation or AADs.
Secondary Outcomes: AF burden: average AF amount per day measured using 1-, 3- or 7-day Holter monitoring at baseline (before ablation), 6, 12 months after PFA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App education group | Experimental | Other: AF application enhancing AF education |
| No-App education group | Experimental | Other: AF application without enhancing AF education and drug adhrence |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who were treated with the FARAPULSE™ PFA for AF as a de novo procedure
- Subjects who are willing and capable of providing informed consent
- 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
Key exclusion criteria (14 listed)
- Subjects with a current interatrial baffle or patch
- Subjects with a known or suspected atrial myxoma
- Subjects with myocardial infarction within 14 days prior to enrollment
- Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
- Subjects who do not tolerate anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF application enhancing AF educationThis group will use AF-application. The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires. | Other | App education group |
| AF application without enhancing AF education and drug adhrenceThis group will use AF-application. However, this application will not contain materials enhancing AF education and adherence. | Other | No-App education group |
Primary outcome
AF freedom at 12 months post-index procedure.
Time frame: average AF amount per day measured using 1-, 3- or 7-day Holter monitoring at baseline (before ablation), 6, 12 months after PFA.
Freedom from recurrence of individual types of AF, or new AFLs or Ats between 3 month and 12-Month follow-up requiring additional ablation or AADs
7 secondary outcomes
Atrial fibrillation (AF) burden
Time frame: upto 12 month follow-up
time to stroke (ischemic and hemorrhagic)
Time frame: upto 12 month follow-up
time to transient ischemic attack (TIA)
Time frame: upto 12 month follow-up
time to systemic embolism
Time frame: upto 12 month follow-up
time to major bleeding
Time frame: upto 12 month follow-up
time to clinically relevant non-major bleeding
Time frame: upto 12 month follow-up
time to hospitalization events
Time frame: upto 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF application enhancing AF education and AF application without enhancing AF education and drug adhrence in people with Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF freedom at 12 months post-index procedure. (time frame: average AF amount per day measured using 1-, 3- or 7-day Holter monitoring at baseline (before ablation), 6, 12 months after PFA.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.