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The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00057 | Experimental | All subjects are enrolled into this arm and will have ECG measurements obtained |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo INVSENSOR00057 | Device | Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 | Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection | Approximately 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Clinical Lab | Irvine | California | 92618 | United States | ||
| PCA Cardiology |
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| ID | Title | Description |
|---|---|---|
| FG000 | INVSENSOR00057 | All subjects are enrolled into this arm and will have ECG measurements obtained Masimo INVSENSOR00057: Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00057 | All subjects are enrolled into this arm and will have ECG measurements obtained Masimo INVSENSOR00057: Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 | Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection | Masimo W1 rhythm classifications were not obtained from 9 subjects (3 from the NSR group, 6 from AFib group) due to the subject not completing the protocol. | Posted | Number | percent | Approximately 30 minutes |
|
|
30 minutes
Definitions do not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INVSENSOR00057 | All subjects are enrolled into this arm and will have ECG measurements obtained Masimo INVSENSOR00057: Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo Corporation | 949-297-7000 | clinicalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2024 | May 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Laguna Hills |
| California |
| 92653 |
| United States |
| Cone Health | Greensboro | North Carolina | 27401 | United States |
| Medication Management | Greensboro | North Carolina | 27405 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
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| 0 |
| 365 |
| 0 |
| 365 |
| 0 |
| 365 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |