Actively Recruiting
Application-Based Integrated Care in Patients After Pulse Field Ablation
Led by Yonsei University · Updated on 2025-11-28
500
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
"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.
CONDITIONS
Official Title
Application-Based Integrated Care in Patients After Pulse Field Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated with the FARAPULSE174; PFA for atrial fibrillation as a first procedure
- Willing and able to provide informed consent
- Willing and able to participate in app-based integrated care
- Age 18 years or older or legal age to give informed consent according to local law
You will not qualify if you...
- Presence of an interatrial baffle or patch
- Known or suspected atrial myxoma
- Myocardial infarction within 14 days before enrollment
- Cerebral vascular accident within 30 days before enrollment
- Unable to tolerate anticoagulation therapy
- Active systemic infection
- Known atrial thrombus
- Inability to obtain vascular access
- Pregnant or planning pregnancy
- Atrial fibrillation caused by reversible or non-cardiac conditions such as electrolyte imbalance, thyroid disease, or alcohol
- Any prosthetic heart valve, ring, or repair including balloon aortic valvuloplasty
- Contraindications to invasive electrophysiology procedures, such as recent cardiac surgery or congenital heart disease that increases ablation risk
- Life expectancy of 1 year or less
- Participation in another investigational study or registry that interferes with this study, except mandatory governmental or purely observational registries
AI-Screening
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Trial Site Locations
Total: 1 location
1
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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