App-based integrated care after FARAPULSE 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

This trial tests whether an app-based integrated care program helps people with atrial fibrillation who had FARAPULSE pulse field ablation stay free of AF and stick to their medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yonsei University (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT07119528 on ClinicalTrials.gov

What this trial studies

This prospective, randomized multicenter trial in South Korea will enroll about 500 patients who undergo de novo FARAPULSE pulse field ablation and randomize them 1:1 to an app-based integrated care program or to locally available standard care. The app includes anticoagulation reminders, education on risk-factor control, medication-adherence prompts, and quality-of-life and cognitive questionnaires, while the control group receives usual follow-up. Patients will be followed at 3, 6, and 12 months, and the primary endpoint is drug-free freedom from atrial fibrillation. The study builds on safety data for pulse field ablation and aims to see if digital integrated care improves post-ablation outcomes.

Who should consider this trial

Good fit: Adults (≥18) who underwent de novo FARAPULSE pulse field ablation for atrial fibrillation, can provide informed consent, and are willing and able to use a smartphone app are ideal candidates.

Not a fit: Patients who cannot use a smartphone, cannot tolerate anticoagulation, have recent myocardial infarction or stroke, active infection, intracardiac thrombus, or other exclusion criteria are unlikely to benefit or are ineligible.

Why it matters

Potential benefit: If successful, the app could improve medication adherence and increase rates of drug-free AF freedom after PFA, potentially reducing stroke risk and healthcare visits.

How similar studies have performed: Large registries such as MANIFEST-17K support PFA safety and previous integrated-care programs for AF have improved outcomes, but dedicated app-based integrated care after PFA is relatively new.

Eligibility criteria

Inclusion Criteria:

1. patients who were treated with the FARAPULSE™ PFA for AF as a de novo procedure
2. Subjects who are willing and capable of providing informed consent
3. 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

Exclusion Criteria:

1. Subjects with a current interatrial baffle or patch
2. Subjects with a known or suspected atrial myxoma
3. Subjects with myocardial infarction within 14 days prior to enrollment
4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
5. Subjects who do not tolerate anticoagulation therapy
6. Subjects with an active systemic infection \*
7. Subjects with a presence of atrial known thrombus \*
8. Subjects with a known inability to obtain vascular access
9. Subjects who are pregnant or planning to be pregnant
10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
11. Subjects with any prosthetic heart valve, ring, or repair including balloon aortic valvuloplasty
12. 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)
13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion
14. 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.

Where this trial is running

Seoul

• Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine — Seoul, South Korea (RECRUITING)

Conditions: Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial fibrillation, Pulse field ablation, Integrated care, Application