Masimo Heartbeat Detection for Healthy Subjects

Overseen By Ahmed Alghazi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masimo Corporation

Disqualifiers: Cardiac disease, Pregnancy, Skin conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new algorithm that detects irregular heartbeats using devices worn on the finger or wrist. The goal is to determine how accurately these devices can identify irregular heartbeats compared to a standard heart monitor. It suits healthy individuals without heart conditions or skin issues on their hands or chest. Participants must be comfortable reading and speaking English to follow study procedures. As an unphased study, this trial allows participants to contribute to innovative research that could improve future heart health monitoring technologies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on healthy subjects without known cardiac conditions, so it's best to ask the study staff for clarification.

What prior data suggests that the Masimo Irregular Heartbeat Detection Algorithm is safe for use?

Research shows that the Masimo Irregular Heartbeat Detection Algorithm is under study to confirm its safety and effectiveness. Although the study is ongoing, early results suggest positive responses to the algorithm, with no major short-term side effects reported.

The device has previously monitored heart rates and detected irregular heartbeats, providing reassurance about its safety. This background indicates that the technology in this trial has been tested in similar situations without major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods for detecting irregular heartbeats, which often rely on bulky equipment and clinical settings, the Masimo Irregular Heartbeat Detection Algorithm is evaluated using portable devices like those worn on the finger or wrist. Researchers are excited about this trial because it aims to demonstrate the algorithm's specificity compared to established ECG devices, offering a potentially more convenient and accessible way to monitor heart health. By enabling continuous and unobtrusive monitoring, this technology could revolutionize how we detect and manage heart rhythm issues, making it easier for people to track their heart health in everyday life.

What evidence suggests that the Masimo Irregular Heartbeat Detection Algorithm is effective for detecting irregular heartbeats?

Research has shown that the Masimo Irregular Heartbeat Detection algorithm identifies irregular heartbeats, such as atrial fibrillation, by comparing its results with a standard ECG. This trial will evaluate the algorithm's specificity for both finger and wrist form factors, assessing each independently. Studies indicate that it effectively detects irregular heartbeats using noninvasive sensors, which are easy to use. Early data suggests that this algorithm reliably matches the accuracy of traditional ECG methods. This could make it a useful tool for continuous heart monitoring outside a clinical setting. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals without any cardiovascular diseases. Specific eligibility criteria are not detailed, but typically participants should have no known heart conditions and be in a general state of good health.

Inclusion Criteria

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)

I am between 18 and 80 years old.

Exclusion Criteria

Subject is pregnant or breastfeeding

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Specificity measure of performance of the Irregular Heartbeat Detection algorithm against the Masimo Radius VSM® reference ECG

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Masimo Irregular Heartbeat Detection Algorithm

Trial Overview The study is testing the accuracy of Masimo's Irregular Heartbeat Detection algorithm in two devices: one worn on the finger (Masimo SET®) and one worn on the wrist (Masimo W1®). Each device's performance will be compared to a standard ECG monitor (Masimo Radius VSM®).

How Is the Trial Designed?

Group I: Specificity of Irregular Heartbeat Detection Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Masimo Corporation

Lead Sponsor

Trials

117

Recruited

13,500+

Katie Szyman

Masimo Corporation

Chief Executive Officer

BA from the University of St. Thomas, MBA from Harvard Business School

Dr. Bilal Muhsin

Masimo Corporation

Chief Medical Officer since 2024

MD from Harvard Medical School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223164

Validation of the Masimo Irregular Heartbeat Detection ... An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers. Adverse event.

2. trialstoday.org trialstoday.org/trial/NCT07223164

Validation of the Masimo Irregular Heartbeat Detection ... Purpose. Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05472012

Performance of Masimo INVSENSOR00057 in Detecting ... This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7316129/

Wearable Devices for Ambulatory Cardiac Monitoring Ambulatory monitoring devices are enabling a new paradigm of health care by collecting and analyzing long-term data for reliable diagnostics.

5. ccjm.org ccjm.org/content/91/1/23

Consumer-grade wearable cardiac monitors: What they do ... The key outcomes are the detection of atrial fibrillation in patients with no prior history of atrial fibrillation and improved adherence to ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf25/K250757.pdf?utm_source=radaislice.com

May 29, 2025 Masimo Corporation Jazmin Laidet Regulatory ... The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure ...

7. mymasimo.com mymasimo.com/globalassets/assets/pdf/_resources/lab-11625e_master2.pdf

MASIMO W 1® The Masimo W1 measures heart rate and checks the ECG rhythm for signs of atrial fibrillation (a common form of arrhythmia) for heart rates of 50 to 150 bpm.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0020138319307144

Are current wireless monitoring systems capable of ... Current systems for wireless patient monitoring are capable to detect abnormalities in vital signs of patients that developed adverse events.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223498.pdf

June 1, 2023 Masimo Corporation Kertana Shankar ... Both features allow the system to reset and re-start the detection of Arrhythmias using newly captured ECG data. 3.1.4. Noninvasive Blood ...