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NCT03492554 · ClinicalTrials.gov registry record · NA
Electrocardiogram Clinical Validation Study
A NA study of Atrial Fibrillation, sponsored by Apple.
- Completed
- Registry status
- NA
- Development phase
- 602
- Enrollment target
- 5
- Study locations
NCT03492554: Completed NA study of Atrial Fibrillation, sponsored by Apple.
NCT03492554 is a NA study of Atrial Fibrillation that has completed, run by Apple. The registered enrollment target is 602 participants, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (80% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03492554, a NA study of Atrial Fibrillation, has completed, sponsored by Apple.
- COMPLETED
- Registry status
- NA
- Development phase
- 602 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.
Primary Outcome
Specificity of rhythm classification
Conditions Studied
Interventions
- OTHER 1-Lead ECG
- DEVICE 12-Lead ECG
Study Locations (5)
Florida
- QPS - Miami
- BioClinicia- Orlando - Orlando
- BioClinica- The Villages - The Villages
Kansas
- IQVIA - Overland Park
Minnesota
- Health East - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2018-03-12 |
| Est. Completion | 2018-05-14 |
| Phase | NA |
What the finished NCT03492554 record still lists
NCT03492554 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which 1-Lead ECG is the first listed.
NCT03492554 lists 5 locations in 3 states (Florida, Kansas, Minnesota).
Frequently Asked Questions
What is clinical trial NCT03492554 about?
NCT03492554 is a clinical study titled "Electrocardiogram Clinical Validation Study". The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or A...
What is the current status of trial NCT03492554?
This trial is currently completed. It is a NA study. The enrollment target is 602 participants. The study started on 2018-03-12. Estimated completion is 2018-05-14.
What conditions does trial NCT03492554 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT03492554?
The interventions under investigation include: 1-Lead ECG (OTHER), 12-Lead ECG (DEVICE).
Who is sponsoring clinical trial NCT03492554?
This trial is sponsored by Apple, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03492554 being conducted?
This trial has 5 study locations across Florida, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03492554's enrollment target sits among peer trials
602 52nd of 202 higher than 151 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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.
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