Atrial FibrillationNCT04380415
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
A study testing Single lead ambulatory ECG patch in people with Atrial Fibrillation, run by Fitbit LLC at 2 sites in United States.
Trial summary
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Single lead ambulatory ECG patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2020to 8 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 22 years of age or older
- Capable of giving informed consent
- U.S. resident
- No prior history of atrial fibrillation or atrial flutter
- Fitbit account, with one of the following devices paired:
- Ionic, Versa, Versa Lite, Versa 2, Versa 3, Charge 3, Charge 4, Inspire HR, Inspire 2, or Sense updated to the latest available firmware.
Who cannot join
- Diagnosis or history of Atrial Fibrillation at time of consent
- Diagnosis or history of Atrial Flutter at time of consent
- Current use of anticoagulation medication
- Cardiac pacemaker or implantable cardioverter-defibrillator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
PlushCare
San Francisco, California, 94107
About this study
Official title: Fitbit Atrial Fibrillation From PPG Data Validation Study
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
- Conditions
- Atrial Fibrillation
- Being tested
- Single lead ambulatory ECG patch
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single lead ambulatory ECG patchDiagnostic test
Single lead ambulatory ECG patch worn on the chest
| Study group | Role | What they receive |
|---|---|---|
| Detection Notification | Active comparator | Pulse rate data will be collected from a commercial device worn on the wrist. ECG will be collected from a single lead ambulatory ECG patch worn on the chest. The data from both the commercial wrist-worn device and the ECG patch are not analyzed real-time. Receives: Diagnostic Test: Single lead ambulatory ECG patch |
| Non Detection Notification | No intervention | Pulse rate data will be collected from a commercial device worn on the wrist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simultaneous measurement of AF ≥ 30 seconds with detection
Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring.
Measured: 7 days
Secondary outcomes (1)
Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms
Simultaneous measurement of AF ≥ 30 seconds on the ECG patch monitor during each of the pulse tachograms that contributed to the first Irregular Heart Rhythm Detection, among those detections confirmed by ECG.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start6 May 2020
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fitbit LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Lubitz, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380415
- Sponsor's protocol ID
- 129-0469-01
- Status last verified
- Feb 2021
- First submitted
- 5 May 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lubitz SA, McConnell MV, Selvaggi C, Krishnamoorthy A, Atlas SJ, McManus DD, Pagoto S, Singer DE, Pantelopoulos A, Foulkes AS, Faranesh AZ. Wearable Irregular Heart Rhythm Detection Recurrences and Electrocardiographic Atrial Fibrillation Confirmation: The Fitbit Heart Study. Circ Arrhythm Electrophysiol. 2025 Jul;18(7):e013565. doi: 10.1161/CIRCEP.124.013565. Epub 2025 Jun 25.
PubMed 40557492Lubitz SA, Faranesh AZ, Selvaggi C, Atlas SJ, McManus DD, Singer DE, Pagoto S, McConnell MV, Pantelopoulos A, Foulkes AS. Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study. Circulation. 2022 Nov 8;146(19):1415-1424. doi: 10.1161/CIRCULATIONAHA.122.060291. Epub 2022 Sep 23.
PubMed 36148649
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitbit Atrial Fibrillation From PPG Data Validation Study
- ClinicalTrials.gov ID
- NCT04380415
- Acronym / sponsor ID
- 129-0469-01
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450,000 participants (actual)
- Lead sponsor
- Fitbit LLCIndustry (pharma, biotech, devices)
- Study start
- 6 May 2020 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Detection Notification | Active comparator | Diagnostic Test: Single lead ambulatory ECG patchPulse rate data will be collected from a commercial device worn on the wrist. ECG will be collected from a single lead ambulatory ECG patch worn on the chest. The data from both the commercial wrist-worn device and the ECG patch are not analyzed real-time. |
| Non Detection Notification | No intervention | –Pulse rate data will be collected from a commercial device worn on the wrist. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 22 years of age or older
- Capable of giving informed consent
- U.S. resident
- No prior history of atrial fibrillation or atrial flutter
- Fitbit account, with one of the following devices paired:
Key exclusion criteria (4 listed)
- Diagnosis or history of Atrial Fibrillation at time of consent
- Diagnosis or history of Atrial Flutter at time of consent
- Current use of anticoagulation medication
- Cardiac pacemaker or implantable cardioverter-defibrillator
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 |
|---|---|---|
| Single lead ambulatory ECG patchSingle lead ambulatory ECG patch worn on the chest | Diagnostic test | Detection Notification |
Primary outcome
Simultaneous measurement of AF ≥ 30 seconds with detection
Time frame: 7 days
Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring.
1 secondary outcome
Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 40557492Lubitz SA, McConnell MV, Selvaggi C, Krishnamoorthy A, Atlas SJ, McManus DD, Pagoto S, Singer DE, Pantelopoulos A, Foulkes AS, Faranesh AZ. Wearable Irregular Heart Rhythm Detection Recurrences and Electrocardiographic Atrial Fibrillation Confirmation: The Fitbit Heart Study. Circ Arrhythm Electrophysiol. 2025 Jul;18(7):e013565. doi: 10.1161/CIRCEP.124.013565. Epub 2025 Jun 25.
- Derived from this study: PubMed 36148649Lubitz SA, Faranesh AZ, Selvaggi C, Atlas SJ, McManus DD, Singer DE, Pagoto S, McConnell MV, Pantelopoulos A, Foulkes AS. Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study. Circulation. 2022 Nov 8;146(19):1415-1424. doi: 10.1161/CIRCULATIONAHA.122.060291. Epub 2022 Sep 23.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Steven Lubitz, MD, MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single lead ambulatory ECG patch in people with Atrial Fibrillation, run by Fitbit LLC at 2 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 6 inclusion and 4 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 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Simultaneous measurement of AF ≥ 30 seconds with detection (time frame: 7 days). 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 NCT04380415, which also lists 2 linked publications.
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 9 Mar 2021.