App-based integrated care after FARAPULSE pulse field ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
  Seoul, South Korea Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Autologous adipose-derived stem cell injections for knee osteoarthritis

  We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.

  Recruiting at 3 sites Yonsei University · Incheon and 2 other locations · NCT07901790

• SVF cellular mix, secretome, and knee response in osteoarthritis

  This study tests the cellular composition and secretome of research-only adipose-derived SVF in adults with knee OA who are already planned to receive an autologous SVF injection as part of their care.

  Recruiting Yonsei University · Seoul · NCT07898501

• 2-mm subchondral drilling vs sequential 4-mm and 2-mm drilling during CARTISTEM implantation for knee cartilage defects

  This study tests whether drilling the knee with a 2-mm drill alone works as well as sequential 4-mm then 2-mm drilling when combined with CARTISTEM treatment for medial knee cartilage defects.

  Recruiting Yonsei University · Seoul · NCT07881445

• Blood biomarker cohort for memory disorders in older adults

  This observational cohort will collect blood samples and brain imaging data from adults 50+ with memory disorders and a small group of healthy young adults to help find biomarkers.

  Recruiting Yonsei University · Seoul, Seodamun-gu · NCT07880275

• Difference in finger, earlobe, and forehead oxygen levels to predict outcomes in dyspnea

  In adults with breathing trouble, this study tests whether differences in SpO2 readings from different body sites can predict who might have worse outcomes.

  Recruiting Yonsei University · Seoul, Seoul · NCT07824414

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.