At a glance
ClinicalIndex Comparison RecordN/ACompleted· 602 enrolled
Drug / intervention
1-Lead ECG +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Electrocardiogram Clinical Validation Study
In Brief
A clinical study evaluating 1-Lead ECG and 12-Lead ECG for Atrial Fibrillation. Completed, enrolled 602 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
CollaboratorsIQVIA Pty Ltd
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
Enrollment StartMar 2018
First PostedApr 2018
Primary CompletionMay 2018
TodayJul 2026
First PostedApr 10, 2018
Enrollment StartMar 12, 2018
Primary CompletionMay 14, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.2 years ago
Interventions
1-Lead ECGother
All participants will record three single-lead ECGs
12-Lead ECGdevice
All participants will simultaneously record three 12-lead ECGs