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Behavioural Intervention
Apple Watch for Atrial Fibrillation Detection
N/A
Waitlist Available
Led By Xiaoxi Yao, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test if Apple Watch can detect early signs of atrial fibrillation, a form of irregular heart rhythm.
Who is the study for?
This trial is for individuals who've had a specific ECG at Mayo Clinic and are at high risk of undetected atrial fibrillation, based on an AI-ECG score. Men must have a CHA2DS2-VASc2 score of 2 or higher; women need a score of 3 or more. It's not for those already diagnosed with atrial fibrillation, dementia, end-stage kidney disease, history of brain bleeding, or those with certain heart devices.Check my eligibility
What is being tested?
The REGAL study is testing if the Apple Watch can be used as a long-term monitoring tool to spot early signs of atrial fibrillation—a heart condition that causes irregular heartbeat—by comparing it against traditional detection methods.See study design
What are the potential side effects?
Since this trial involves using an Apple Watch for monitoring purposes rather than medication or invasive procedures, there may be minimal side effects related to wearing the device such as skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at a higher risk for stroke due to my heart condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atrial fibrillation
Secondary outcome measures
Change in individuals' maximum learning span
Change in processing speed measure
Ischemic stroke or systemic embolism events
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Apple Watch Intervention GroupExperimental Treatment1 Intervention
Participants will be asked to wear an Apple Watch and use the Mayo Clinic ECG Study App to collect and share data with the study team.
Group II: Control GroupActive Control1 Intervention
Participants will receive usual care.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,765,083 Total Patients Enrolled
32 Trials studying Atrial Fibrillation
11,588 Patients Enrolled for Atrial Fibrillation
Xiaoxi Yao, PhDPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dementia.I have had bleeding in my brain before.You have a device inside your body to monitor your heart, like a pacemaker or defibrillator.You had a specific heart test called a 12-lead ECG at Mayo Clinic that lasted for 10 seconds.You have a high score that suggests a high chance of having a heart condition called atrial fibrillation.My kidneys are in the final stage of failure.I am at a higher risk for stroke due to my heart condition.I have been diagnosed with atrial fibrillation.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacant slots available for prospective participants of the research?
"Unfortunately, this medical experiment is not presently looking for volunteers. This trial was posted on September 1st 2023 and its last update was June 20th 2023. However, there are 496 other studies in need of participants today."
Answered by AI
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