Clinical Trial

Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease

Completed
View on ClinicalTrials.gov →
Summary
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG. Each form factor will be evaluated independently of one another
Protocol Amendment History 5 changes
critical Trial completed 2026-07-31
critical Primary endpoint(s) modified 2026-07-31
notable Enrollment reduced: 120 -> 102 participants 2026-07-31
notable Primary completion moved earlier: 2026-10-01 -> 2025-10-31 2026-07-31
minor Completion moved earlier: 2026-10-01 -> 2025-10-31 2026-07-31
Trial Details
NCT Number NCT07223164
Lead Sponsor Masimo Corporation
Conditions Healthy
Enrollment 102 participants
Start Date 2025-10-21
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30