NCT04468321Completed
Heart Watch Study: a Pragmatic Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Apr 2025
Brief summary (registry, in English)
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-reported and clinical outcomes at 6 months and up to 1 year.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 7 Jul 2020
- Start date
- 18 Aug 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Yale University
- Diseases
- Atrial fibrillation
- NCT number
- NCT04468321
What you commit to
- Study type: Interventional
- Participants enrolled: 105
- From 18 Aug 2021 to the primary completion date, 1 Dec 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- No exclusion criteria
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.