An interventional study of AF application enhancing AF education and AF application without enhancing AF education and drug adhrence in Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care
"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.
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.
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This study's planned enrollment of 500 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
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Exclusion Criteria:
Other: AF application enhancing AF education
Other: AF application without enhancing AF education and drug adhrence
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.
This group will use AF-application. However, this application will not contain materials enhancing AF education and adherence.
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: upto 12 month follow-up
Plan to share: No
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