ovel anticoagulation therapy using Apple Watch
- Conditions
- Atrial Fibrillation
- Registration Number
- JPRN-jRCTs052230070
- Lead Sponsor
- Sakata Yasushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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 <= 3
5. Age => 22
6. Signed informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in the total number of days of DOACs taken during the total observation period (days 31-360 (or date of study discontinuation))
- Secondary Outcome Measures
Name Time Method [Efficacy]<br>(1) All bleeding events up to 360 days after study entry<br>(2) Major bleeding up to 360 days after study entry<br>(3) All-cause mortality up to 360 days after study entry<br>(4) Cerebral infarction and systemic embolism up to 360 days after the start of the study<br><br>[Safety]<br>Diseases, etc.<br><br>[Malfunction]<br>Malfunction in heart rate notifications, or ECG recording