Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04380415 · ClinicalTrials.gov registry record · NA
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
A NA study, sponsored by Fitbit.
- Completed
- Registry status
- NA
- Development phase
- 450,000
- Enrollment target
NCT04380415: Completed NA study, sponsored by Fitbit.
NCT04380415 is a NA study that has completed, run by Fitbit. The registered enrollment target is 450,000 participants, above the 1,396-participant average among 58,714 other NA trials with a reported enrollment target (32135% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04380415, a NA study, has completed, sponsored by Fitbit.
- COMPLETED
- Registry status
- NA
- Development phase
- 450,000 participants
- Enrollment target
Study Summary
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Single lead ambulatory ECG patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450,000 participants |
| Start Date | 2020-05-06 |
| Est. Completion | 2021-03-08 |
| Phase | NA |
What the finished NCT04380415 record still lists
NCT04380415 is an interventional study that assigns participants to a tested intervention. Its 450,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,396-participant average among 58,714 other NA trials with a reported enrollment target (32135% higher).
The record links to 0 conditions, and to 1 intervention - of which Single lead ambulatory ECG patch is the first listed.
NCT04380415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04380415 about?
NCT04380415 is a clinical study titled "Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch". Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
What is the current status of trial NCT04380415?
This trial is currently completed. It is a NA study. The enrollment target is 450,000 participants. The study started on 2020-05-06. Estimated completion is 2021-03-08.
What interventions are being tested in trial NCT04380415?
The interventions under investigation include: Single lead ambulatory ECG patch (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04380415?
This trial is sponsored by Fitbit, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04380415's enrollment target sits among peer trials
450,000 1st of 2000 higher than 2,000 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06342375 · 425,000 participants · NA
Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage
- NCT05065060 · 500,000 participants
Parkinson Progression Marker Initiative Online (PPMI Online)
- NCT06017687 · 500,000 participants · NA
Data Collection and Evaluation of OptiBP Under Investigational Use
- NCT06934239 · 400,000 participants · Phase 4
A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI