Status:
COMPLETED
Heart Watch Study: a Pragmatic Randomized Controlled Trial
Lead Sponsor:
Yale University
Collaborating Sponsors:
Mayo Clinic
Duke University
Conditions:
Cardioversion
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This will be a prospective multi-center, randomized, controlled trial of 150 patients conducted to assess the impact of individual use of the Apple Watch compared to the Withings Move on patient-repor...
Detailed Description
This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 6 compared to the Withings Move on both patient-reported outcomes and clinical utilization over 6 months and ...
Eligibility Criteria
Inclusion
- Age \>22
- English-speaking
- 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 is willing and able to read and sign consent and participate in study
- Participant lives independently and does not require continuous care
- Participant has an email account (or is willing to create one)
- Participant has a compatible smartphone (iPhone 6s or later)
- Participant is willing to wear only the device they are randomized to receive for the study period for as many hours during the day as they are able, except for time spent charging the device or in environments that may be suboptimal for the device
- Participant is willing to use the Hugo mobile health platform and Apple Watch Series 6 or Withings Move
- Participant has cardiology care at YNHH, Duke Health, or Mayo Clinic
Exclusion
- No exclusion criteria
Key Trial Info
Start Date :
August 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04468321
Start Date
August 18 2021
End Date
June 1 2024
Last Update
April 18 2025
Active Locations (3)
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1
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Duke University Medical Center
Durham, North Carolina, United States, 27710