Heart Watch Study: a Pragmatic Randomized Controlled Trial

NCT04468321 | Completed Results DMC FDA Device

• 2 other identifiers: 20000281266292-2020-R2TC-T12T13
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

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-reported and clinical outcomes at 6 months and up to 1 year.

Conditions

Cardioversion; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)

  Change in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 6 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 6 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome.

  baseline and 6 months

Secondary Outcomes (19)

• Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)

  baseline and 12 months

• Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms

  6 months

• Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms

  12 months

• Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities

  6 months

• Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities

  12 months

Study Arms (2)

Apple Watch

EXPERIMENTAL

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

Device: Apple Watch

Withings Move

PLACEBO COMPARATOR

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

Device: Withings Move

Interventions

Apple Watch DEVICE

Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.

Apple Watch

Withings Move DEVICE

Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.

Withings Move

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Mayo Clinic: collaborator
• Duke University: collaborator
• National Evaluation System for health Technology Coordinating Center: collaborator

Study Sites (3)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Dhruva SS, Shah ND, Vemulapalli S, Deshmukh A, Beatty AL, Gamble GM, Freeman JV, Hummel JP, Piccini JP, Akar JG, Ervin K, Arges KL, Emanuel L, Noseworthy PA, Hu T, Bartlett V, Ross JS. Heart Watch Study: protocol for a pragmatic randomised controlled trial. BMJ Open. 2021 Dec 30;11(12):e054550. doi: 10.1136/bmjopen-2021-054550.

  PMID: 35234659 DERIVED

Related Links

• Preprint of protocol manuscript

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joseph Ross, MD, MHS
• Organization: Yale University

joseph.ross@yale.edu

2037852987

Study Officials

• Joseph Ross, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

• Peter Noseworthy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Sreekanth Vemulapalli, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Sanket Dhruva, MD, MHS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 13, 2020
• Study Start: August 18, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: April 18, 2025
• Results First Posted: December 20, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available once the study has been completed.

Locations

US (3)