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This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00057 | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00057 | Device | Noninvasive wearable health monitoring device |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor. | 1-5 hours |
| Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor. | 1-5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Jackson | Tennessee | 38301 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | INVSENSOR00057 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device. INVSENSOR00057: Noninvasive wearable health monitoring device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00057 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device. INVSENSOR00057: Noninvasive wearable health monitoring device |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor. | A total of 23 subjects were excluded from the data analysis based on the protocol criteria. This included individuals whose reference or test ECG did not provide readable waveforms, as determined by medical personnel, and those who appeared to have atrial fibrillation (Afib) at enrollment but provided waveforms that were inconsistent with an Afib diagnosis. | Posted | Number | % of true positive | 1-5 hours |
|
1-5 hours
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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 who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device. INVSENSOR00057: Noninvasive wearable health monitoring device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm Cramp | Injury, poisoning and procedural complications | Non-systematic Assessment | The subject's arm experienced a cramp during the study, but the study continued once the cramp subsided. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo | 949-297-7000 | studies@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 | Jun 27, 2022 | May 6, 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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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor. | A total of 23 subjects were excluded from the data analysis based on the protocol criteria. This included individuals whose reference or test ECG did not provide readable waveforms, as determined by medical personnel, and those who appeared to have atrial fibrillation (Afib) at enrollment but provided waveforms that were inconsistent with an Afib diagnosis. | Posted | Number | % of true negative | 1-5 hours |
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| 0 |
| 139 |
| 0 |
| 139 |
| 1 |
| 139 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |