CardioversionNCT04468321
Heart Watch Study: a Pragmatic Randomized Controlled Trial
A study testing Apple Watch and Withings Move in people with Cardioversion and Atrial Fibrillation, run by Yale University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cardioversion, Atrial Fibrillation
- What is being tested?
- Apple Watch and Withings Move
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Aug 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- No exclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read the 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 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.
- Conditions
- Cardioversion, Atrial Fibrillation
- Being tested
- Apple Watch, Withings Move
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple WatchDevice
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.
Withings MoveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Apple Watch | Experimental | Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. Receives: Device: Apple Watch |
| Withings Move | Placebo comparator | Patients will be provided with the Withings Move with activity tracking. Receives: Device: Withings Move |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
Secondary outcomes (19)
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 12 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 12 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome.
Measured: baseline and 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
Difference within individual Symptoms domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
Difference within individual Symptom domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
Difference within individual Daily Activities domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
Difference within individual Daily Activities domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
Difference within individual Treatment Concern domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
Difference within individual Treatment Concern domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
Difference within individual Treatment Satisfaction domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
Difference within individual Treatment Satisfaction domain of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12-month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
Measured: 12 months
Proportion of Patients Taking Anticoagulants
Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
Measured: 6 months
Proportion of Patients Taking Anticoagulants
Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
Measured: 12 months
Proportion of Participants With Acute Care Use at 6 Months
Acute care use will be compared between the two groups at 6 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 6 month period.
Measured: 6 months
Proportion of Participants With Acute Care Use at 12 Months
Acute care use will be compared between the two groups at 12 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 12 month period.
Measured: 12 months
Proportion of Participants With Outpatient Care Use at 6 Months
Outpatient care use will be compared between the two groups at 6 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.
Measured: 6 months
Proportion of Participants With Outpatient Care Use at 12 Months
Outpatient care use will be compared between the two groups at 12 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.
Measured: 12 months
Proportion of Participants With Rhythm-related Diagnostic Testing at 6 Months
Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors
Measured: 6 months
Proportion of Participants With Rhythm-related Diagnostic Testing at 12 Months
Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors
Measured: 12 months
Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter
A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 6 month period. The medication data will be obtained primarily from electronic health record data.
Measured: 6 months
Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter
A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 12 month period. The medication data will be obtained primarily from electronic health record data.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start18 Aug 2021
- Primary completion1 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardioversionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Duke University, National Evaluation System for health Technology Coordinating Center
- Responsible party
- Sponsor
- Investigators
- Joseph Ross, MD, MHS, Principal investigator, Yale UniversityPeter Noseworthy, MD, Principal investigator, Mayo ClinicSreekanth Vemulapalli, MD, Principal investigator, Duke UniversitySanket Dhruva, MD, MHS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468321
- Sponsor's protocol ID
- 2000028126
- Other IDs
- 6292-2020-R2TC-T12T13
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2020
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes
Publications
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.
PubMed 35234659
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Watch Study: a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04468321
- Acronym / sponsor ID
- 2000028126
- Conditions
- Cardioversion, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, Duke University, National Evaluation System for health Technology Coordinating Center
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple Watch | Experimental | Device: Apple WatchPatients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. |
| Withings Move | Placebo comparator | Device: Withings MovePatients will be provided with the Withings Move with activity tracking. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple WatchParticipants 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. | Device | Apple Watch |
| Withings MoveParticipants 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. | Device | Withings Move |
Primary outcome
Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
Time frame: baseline and 6 months
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.
19 secondary outcomes
Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
Time frame: baseline and 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
Time frame: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
Time frame: 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
Time frame: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
Time frame: 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
Time frame: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
Time frame: 12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
Time frame: 6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
Time frame: 12 months
Proportion of Patients Taking Anticoagulants
Time frame: 6 months
Proportion of Patients Taking Anticoagulants
Time frame: 12 months
Proportion of Participants With Acute Care Use at 6 Months
Time frame: 6 months
Proportion of Participants With Acute Care Use at 12 Months
Time frame: 12 months
Proportion of Participants With Outpatient Care Use at 6 Months
Time frame: 6 months
Proportion of Participants With Outpatient Care Use at 12 Months
Time frame: 12 months
Proportion of Participants With Rhythm-related Diagnostic Testing at 6 Months
Time frame: 6 months
Proportion of Participants With Rhythm-related Diagnostic Testing at 12 Months
Time frame: 12 months
Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter
Time frame: 6 months
Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35234659Dhruva 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.
- Individual participant dataSharing planned: Yes. Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ross, MD, MHS principal investigator
Yale University
Peter Noseworthy, MD principal investigator
Mayo Clinic
Sreekanth Vemulapalli, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Watch and Withings Move in people with Cardioversion and Atrial Fibrillation, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04468321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.