What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation include antiarrhythmic drugs and wearable monitoring technologies. Antiarrhythmic drugs like dronedarone can significantly increase the risk of cardiovascular events, including stroke, myocardial infarction, and heart failure, and require regular ECG monitoring to ensure AF has not become permanent. Ibutilide, used for rapid conversion of AF, can cause arrhythmias and requires careful dosing. Wearable technologies like the Apple Watch can accurately monitor heart rate in AF patients but may not replace traditional ECGs for definitive diagnosis. These devices can help in early detection and management but should be used with caution and in conjunction with professional medical advice.

What prior FDA approvals exist?

The FDA has approved several treatments for atrial fibrillation, including antiarrhythmic drugs like dronedarone, which has shown both benefits and risks in clinical trials. Additionally, the use of wearable technology for AF detection and monitoring has been explored, as seen in trials like the WATCH AF trial, which evaluated the diagnostic accuracy of smartwatches using photoplethysmographic signals. These advancements highlight the growing role of technology in managing AF, complementing traditional pharmacologic therapies.

What other types of research exist?

Promising alternatives to the Apple Watch and Withings Move for AF patients include the AF-EduApp, which integrates education and self-care modules, and the Textile Wearable Holter (TWH), which has shown feasibility in continuous monitoring and AF detection. Additionally, smartwatches using photoplethysmographic (PPG) signals, as validated in the WATCH AF trial, offer accurate AF detection and could be considered for comprehensive remote management.

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Smartwatch Monitoring for Atrial Fibrillation

N/A

Waitlist Available

Led By Joseph Ross, MD, MHS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned for direct current cardioversion or catheter ablation for atrial fibrillation or atrial flutter, as noted by referring clinical staff or on chart review

Participant lives independently and does not require continuous care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is comparing the Apple Watch Series 6 with the Withings Move to see how they impact patients with heart rhythm issues after treatment. The Apple Watch can monitor heart activity and alert users to irregular heartbeats, potentially improving health outcomes. The Apple Watch has been evaluated in several studies for its ability to detect irregular heart rhythms and atrial fibrillation.

Who is the study for?

This trial is for English-speaking adults over 22 with atrial fibrillation or flutter, planning a cardioversion or catheter ablation. They must live independently, have an email and compatible smartphone, and be willing to wear the Apple Watch Series 6 or Withings Move exclusively during the study.

What is being tested?

The Heart Watch Study compares patient-reported outcomes using two different smartwatches: the Apple Watch Series 6 and Withings Move. Participants will use one of these devices to monitor their heart health after treatment for atrial fibrillation.

What are the potential side effects?

There are no direct medical side effects from participating in this trial as it involves consumer electronics (smartwatches) rather than medication. However, participants may experience discomfort or inconvenience from wearing the device continuously.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a procedure to correct my irregular heartbeat.

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I live on my own and do not need constant care.

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I am older than 22 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)

Secondary study objectives

Proportion of participants with acute care use at 12 months

Proportion of participants with acute care use at 6 months

Proportion of participants with clinical treatment for atrial fibrillation or flutter

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Apple WatchExperimental Treatment1 Intervention

Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities.

Group II: Withings MovePlacebo Group1 Intervention

Patients will be provided with the Withings Move with activity tracking.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apple Watch

2022

N/A

~550

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atrial Fibrillation (AF) include rate control, rhythm control, and anticoagulation. Rate control medications, such as beta-blockers and calcium channel blockers, slow the heart rate. Rhythm control uses antiarrhythmic drugs like amiodarone, sotalol, and dofetilide to restore and maintain normal heart rhythm. Anticoagulation therapy, with drugs like warfarin or direct oral anticoagulants, prevents stroke by reducing blood clot formation. Wearable technology, such as the Apple Watch and Withings Move, can monitor heart rate and rhythm, providing real-time data to manage AF more effectively. This is crucial for AF patients as it aids in early detection, monitoring treatment efficacy, and reducing the risk of complications like stroke.