Novel anticoagulation therapy using Apple Watch

JRCT ID: jRCTs052230070

Registered date:19/07/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atrial Fibrillation
• Date of first enrollment: 31/08/2023
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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 days after the start of the study
The study subject must record an ECG with the ECG application, continue taking the DOAC, discontinue monitoring with the Apple Watch, and visit a physician within one week (whenever possible; 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
The subject will resume monitoring with the Apple Watch, continue taking DOACs until Day 30, and in principle stop taking DOACs on Day 31.
- If the physician determines that there is no recurrence of atrial fibrillation on or later
Apple Watch monitoring is resumed and DOAC medication is discontinued.
- If the physician's diagnosis is also atrial fibrillation
Apple Watch monitoring is terminated and DOACs are continued. The subject will continue routine visit.

Discontinuation and termination of Apple Watch monitoring means that the subject will not wear the Apple Watch if it is a loaner Apple Watch, and will turn off the heart rate alert if it is the subject's own Apple Watch.

2) When the heart rate alert does not appear during the first 30 days of the study
The DOAC will be discontinued on Day 31 in principle, and the subject will visit a physician within one week. If the physician does not find atrial fibrillation in the diagnosis, the discontinuation and monitoring are continued.

3) When a heart rate alert is observed after the 31st day of the study
The subject will record an ECG with an ECG application, resume DOAC, discontinue monitoring with Apple Watch, and visit a physician within one week.
- If the physician determines that there is no recurrence of atrial fibrillation
Monitoring with the Apple Watch will be resumed and the DOAC medication will be discontinued.
- If the physician's diagnosis is also atrial fibrillation
Apple Watch monitoring will be terminated and DOAC will be continued.

4) When a heart rate alert is not observed after the 31st day of the study
The subject will continue routine visit.

5) When atrial fibrillation is detected by various electrocardiography tests without the appearance of heart rate alerts after the start of the study
If atrial fibrillation is confirmed by various ECG tests without the appearance of heart rate alerts, such as ECG recording by the subject's voluntary ECG application or ECG tests at other hospitals or at the subject's own hospital, the subject will visit a physician and, after confirmation by the physician, will continue or resume taking DOAC and Apple Watch monitoring will be terminated if atrial fibrillation is determined to be present. If the patient is determined to be in atrial fibrillation after confirmation by the physician, DOAC is continued or resumed and Apple Watch monitoring is terminated. The subject will continue routine visit.

Outcome(s)

• Primary Outcome: 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

[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

Key inclusion & exclusion criteria

• Age minimum: >= 22age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <= 3
5. Age => 22
6. Signed informed consent

Exclude 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

Related Information

• Primary Sponsor: Sakata Yasushi
• Source(s) of Monetary Support: Donations from supporters of the "Research on the best anticoagulant medication for individual patients with atrial fibrillation" project (https://readyfor.jp/projects/handai-af2023) on the crowdfuhttps://readyfor.jp/projects/handai-af2023nding site READYFOR.