NCT07223164 Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
| NCT ID | NCT07223164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Masimo Corporation |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-10-21 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Subject is 18 to 80 years of age. * Comfortable to read and communicate in English.\* * Subject passes the health assessment conducted by qualified study personnel, confirming they are in adequate health to participate in the required procedures * This is to ensure the participant can provide informed consent and can comply with study procedures (as study material are currently available in English only). Exclusion Criteria: * Subject currently has a known cardiac disease condition. * Subject is pregnant or breastfeeding. * Subjects with a skin condition affecting the digits/chest, where the sensors are applied which would interfere with the path of lights (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown) or sensor adhesion. * Skin condition which would preclude proper ECG placement. * Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them. * Subject is allergic to any supplies used in the study (e.g., ECG gel, adhesives). * Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07223164 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07223164 currently recruiting?
Yes, NCT07223164 is actively recruiting participants. Contact the research team at studies@masimo.com for enrollment information.
Where is the NCT07223164 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT07223164 clinical trial?
NCT07223164 is sponsored by Masimo Corporation. The trial plans to enroll 120 participants.