N/A
Completed N=105
Heart Watch Study: a Pragmatic Randomized Controlled Trial
Cardioversion · Atrial Fibrillation
Source: ClinicalTrials.gov NCT04468321 ↗
Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) — 20.3; 17.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) |
23.5; 25.0 | — |
| SECONDARY Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) |
23.5; 25.0 | — |
| SECONDARY Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms |
23.7; 25.3 | — |
| SECONDARY Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities |
27.2; 27.2 | — |
| SECONDARY Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern |
17.6; 21.9 | — |
| SECONDARY Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction |
25.5; 25.0 | — |
| SECONDARY Proportion of Patients Taking Anticoagulants |
90.6; 91.6 | — |
| SECONDARY Proportion of Participants With Acute Care Use at 6 Months |
— | — |
| SECONDARY Proportion of Participants With Acute Care Use at 12 Months |
— | — |
| SECONDARY Proportion of Participants With Outpatient Care Use at 6 Months |
— | — |
| SECONDARY Proportion of Participants With Outpatient Care Use at 12 Months |
— | — |
| SECONDARY Proportion of Participants With Rhythm-related Diagnostic Testing at 6 Months |
— | — |
| SECONDARY Proportion of Participants With Rhythm-related Diagnostic Testing at 12 Months |
— | — |
| SECONDARY Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04468321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.