RecruitingNot ApplicableNCT07119528

Application-Based Integrated Care in Patients After Pulse Field Ablation

Application-Based Integrated Care Approach for Enhancing the Effect of FARAPULSE™ Pulse Field Ablation in Patients With Atrial Fibrillation: Randomized Control Trial


Sponsor

Yonsei University

Enrollment

500 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an app-based care program helps patients recover and stay well after they receive a heart ablation procedure called pulse field ablation (PFA) for atrial fibrillation (AFib). The app supports monitoring, communication, and follow-up care after the procedure. **You may be eligible if...** - You were treated with the FARAPULSE PFA system for AFib as your first ablation procedure - You are 18 or older (or of legal consenting age in your region) - You are willing and able to use a smartphone app for integrated care **You may NOT be eligible if...** - You have a known heart structural abnormality such as an atrial baffle or patch - You have had a previous ablation for AFib - You are unable or unwilling to use digital technology for follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAF application enhancing AF education

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.

OTHERAF application without enhancing AF education and drug adhrence

This group will use AF-application. However, this application will not contain materials enhancing AF education and adherence.


Locations(1)

Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

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NCT07119528