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Smartwatch Monitoring for Atrial Fibrillation

N/A

Waitlist Available

Led By Peter Noseworthy, MD

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

Awards & highlights

Study Summary

This trial will compare how well the Apple Watch and Withings Move help 150 patients with their health outcomes.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

2015

N/A

~440

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,563 Total Patients Enrolled

5 Trials studying Atrial Fibrillation

1,399 Patients Enrolled for Atrial Fibrillation

Mayo ClinicOTHER

3,206 Previous Clinical Trials

3,766,978 Total Patients Enrolled

32 Trials studying Atrial Fibrillation

13,483 Patients Enrolled for Atrial Fibrillation

Duke UniversityOTHER

2,358 Previous Clinical Trials

3,419,964 Total Patients Enrolled

13 Trials studying Atrial Fibrillation

13,216 Patients Enrolled for Atrial Fibrillation

Media Library

Apple Watch Clinical Trial Eligibility Overview. Trial Name: NCT04468321 — N/A

Atrial Fibrillation Research Study Groups: Apple Watch, Withings Move

Atrial Fibrillation Clinical Trial 2023: Apple Watch Highlights & Side Effects. Trial Name: NCT04468321 — N/A

Apple Watch 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468321 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this research project?

"This clinical trial requires 150 people, who meet the given criteria, to participate. Patients can join from a selection of medical facilities such as Rochester's Mayo Clinic and New Haven Connecticut's Yale-New Haven Hospital."

Answered by AI

Is this clinical trial currently enrolling participants?

"Affirmative. Clinicaltrials.gov provides evidence that this trial, which was first published on August 18th 2021 is presently enrolling volunteers. Specifically, 150 patients are required from 3 distinct sites to participate in the study."

Answered by AI

Recent research and studies

BMJ OpenJournal

Heart Watch Study: Protocol for a Pragmatic Randomised Controlled Trial

Dhruva, Sanket S, Nilay D Shah, Sreekanth Vemulapalli, Abhishek Deshmukh, Alexis L Beatty, Ginger M Gamble, James V Freeman, et al.. 2021. “Heart Watch Study: Protocol for a Pragmatic Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-054550.

clinicaltrials.govStudy

Heart Watch Study: a Pragmatic Randomized Controlled Trial

2021. "Heart Watch Study: a Pragmatic Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04468321.

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