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Official title Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
ClinicalTrials.gov ID: NCT07223164
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- This is to ensure the participant can provide informed consent and can comply with study procedures (as study material are currently available in...
You likely can't join if
- Subject currently has a known cardiac disease condition.
- Subject is pregnant or breastfeeding.
- people with a skin condition affecting the digits/chest, where the sensors are applied which would interfere with the path of lights (e.g...
- Skin condition which would preclude proper ECG placement.
- people 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).
See the full eligibility 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).
- Subject currently has a known cardiac disease condition.
- Subject is pregnant or breastfeeding.
- people 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...
- Skin condition which would preclude proper ECG placement.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.