Heart Watch Study: a Pragmatic Randomized Controlled Trial

Yale University

Status: Completed

Conditions: Atrial Fibrillation; Cardioversion

Treatments: Device: Apple Watch; Device: Withings Move

Study type: Interventional

Funder types: Other

Identifiers

NCT04468321

2000028126

6292-2020-R2TC-T12T13 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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 up to 1 year. Our research method will employ a patient-centered health data sharing platform (called Hugo) for real-world surveillance of outcomes in 150 total patients after they receive elective direct current cardioversion (DCCV) or catheter ablation for treatment of atrial fibrillation or atrial flutter. Patients will be enrolled at each of 3 clinical sites: Yale-New Haven Hospital, the Mayo Clinic, and Duke Health. Half of the patients will be randomized to receive the Apple Watch Series 6, while half will receive a control device (Withings Move). Patients will then be queried about specific symptoms related to atrial fibrillation and medication adherence monthly. This project will provide novel and needed post-market data about the Apple Watch Series 6 ECG and irregular rhythm detection notification features and, on a larger scale, help delineate the impact of an innovative digital health technology on real-world patient outcomes.

Specific Aim 1: To assess the impact of using the Apple Watch ECG and irregular rhythm notification features on patient-reported outcomes and clinical utilization after patients receive cardioversion or catheter ablation for atrial fibrillation or atrial flutter.

Specific Aim 2: To determine the accuracy of the Apple Watch ECG compared to physician interpretation of 12-lead ECGs obtained in routine clinical care.

Enrollment: 105 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• No exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups, including a placebo group

Apple Watch

Experimental group

Description:

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

Treatment:

Device: Apple Watch

Withings Move

Placebo Comparator group

Description:

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

Treatment:

Device: Withings Move