Atrial Fibrillation
Conditions
Interventions
Monitoring using the Apple Watch will be initiated in those patients who give consent. The monitoring start date will be the study start date (Day 1).
1) When a heart rate alert appears within 30 day
if more than a week has passed, as soon as possible. The same applies below).
- If the physician determines that there is no recurrence of atrial fibrillation within 30 days of the start of the study
Sponsors
Sakata Yasushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. No AF recurrence after 3 months after catheter ablation 2. Patients using DOACs 3. Patients using iPhone (version 8 or later, SE (second generation or later)) 4. CHA2DS2VASc score 22 6. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Mechanical valve 2. Severe mitral stenosis 3. Cases in which anticoagulation is essential (deep venous thrombosis, intracardiac thrombus, etc.) 4. Heart rate above 100 bpm at rest 5. Pacemaker implantation 6. Implantable cardioverter defibrillator implantation or history of lethal arrhythmias 7. Post-operative cardiac transplantation 8. Chronic hemodialysis 9. Subjects with a history of cerebral infarction 10. Patients scheduled for elective surgery during the observation period, including catheterization 11. Blindness or cognitive impairment 12. Other persons deemed inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in the total number of days of DOACs taken during the total observation period (days 31-360 (or date of study discontinuation)) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy] (1) All bleeding events up to 360 days after study entry (2) Major bleeding up to 360 days after study entry (3) All-cause mortality up to 360 days after study entry (4) Cerebral infarction and systemic embolism up to 360 days after the start of the study [Safety] Diseases, etc. [Malfunction] Malfunction in heart rate notifications, or ECG recording | — |
Contacts
Public ContactAkihiro Sunaga
Graduate School of Medicine, The University of Osaka Hospital
Outcome results
None listed