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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
RECRUITING
Seoul
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 500
Treatments
Experimental: App education group
Experimental: No-App education group
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov