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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation (AF) | Other | Patient with a known history of AF who are in AF at the time of study screening. |
|
| Normal Sinus Rhythm (SR) | Other | Patient with no known diagnosis of AF or other arrhythmia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-Lead ECG | Other | All participants will record three single-lead ECGs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG | Specificity of rhythm classification | 1 Day |
| Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG | Sensitivity of rhythm classification | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference | Number of ECGs that pass a visual overlay | 1 Day |
| Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS | Miami | Florida | 33143 | United States | ||
| BioClinicia- Orlando |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atrial Fibrillation (AF) | Patient with a known history of AF who is in AF at the time of study screening. 1-Lead ECG: All participants will record three single-lead ECGs 12-Lead ECG: All participants will simultaneously record three 12-lead ECGs |
| FG001 | Normal Sinus Rhythm (SR) | Patient with no known diagnosis of AF or other arrhythmia 1-Lead ECG: All participants will record three single-lead ECGs 12-Lead ECG: All participants will simultaneously record three 12-lead ECGs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
14 participants enrolled as SR but had history of paroxysmal AF and therefore excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atrial Fibrillation (AF) | Patient with a known history of AF who is in AF at the time of study screening. 1-Lead ECG: All participants will record three single-lead ECGs 12-Lead ECG: All participants will simultaneously record three 12-lead ECGs |
| BG001 | Normal Sinus Rhythm (SR) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG | Specificity of rhythm classification | Classifiable Analysis Set: All subjects who had readable/classifiable paired Software and Reference strips were used. This analysis set was used for analyzing the primary endpoints of sensitivity and specificity. | Posted | Count of Participants | Participants | 1 Day |
|
1 Day
Adverse Event, Serious Adverse Event or Mortality were assessed/monitored.
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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 | Atrial Fibrillation (AF) | Patient with a known history of AF who is in AF at the time of study screening. 1-Lead ECG: All participants will record three single-lead ECGs 12-Lead ECG: All participants will simultaneously record three 12-lead ECGs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Health Technology Clinical Operations | Apple | 1-866-905-5303 | htclinicalquestions@apple.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 15, 2018 | Nov 17, 2020 | Prot_SAP_001.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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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 12-Lead ECG | Device | All participants will simultaneously record three 12-lead ECGs |
|
Difference in R-wave amplitudes between the software and gold standard reference |
| 1 Day |
| Ease of Use | Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale | 1 Day |
| Orlando |
| Florida |
| 32806 |
| United States |
| BioClinica- The Villages | The Villages | Florida | 32162 | United States |
| IQVIA | Overland Park | Kansas | 66211 | United States |
| Health East | Saint Paul | Minnesota | 55102 | United States |
Patient with no known diagnosis of AF or other arrhythmia 1-Lead ECG: All participants will record three single-lead ECGs 12-Lead ECG: All participants will simultaneously record three 12-lead ECGs |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG | Sensitivity of rhythm classification | Classifiable Analysis Set: All subjects who had readable/classifiable paired Software and Reference strips were used. This analysis set was used for analyzing the primary endpoints of sensitivity and specificity. | Posted | Count of Participants | Participants | 1 Day |
|
|
|
|
| Secondary | Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference | Number of ECGs that pass a visual overlay | Waveform Assessment Analysis Set: Paired Software and Reference strips collected from subjects were randomly selected. If 6 consecutive paired beats for analysis cannot be found in these strips, they were excluded from further analysis. This analysis set was used for assessing the quality of the clinical waveform. | Posted | Count of Participants | Participants | 1 Day |
|
|
|
|
| Secondary | Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference | Difference in R-wave amplitudes between the software and gold standard reference | Waveform Assessment Analysis Set: Paired Software and Reference strips collected from subjects were randomly selected. If 6 consecutive paired beats for analysis cannot be found in these strips, they were excluded from further analysis. This analysis set was used for assessing the quality of the clinical waveform. | Posted | Count of Participants | Participants | 1 Day |
|
|
|
|
| Secondary | Ease of Use | Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale | Posted | Count of Participants | Participants | 1 Day |
|
|
|
| 0 |
| 301 |
| 0 |
| 301 |
| 0 |
| 301 |
| EG001 | Normal Sinus Rhythm (SR) | Patient with no known diagnosis of AF or other arrhythmia 1-Lead ECG: All participants will record three single-lead ECGs 12-Lead ECG: All participants will simultaneously record three 12-lead ECGs | 0 | 301 | 0 | 301 | 0 | 301 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004568 | Electrodiagnosis |
| 3 = Average Ease of Use |
|
| 4 = Above Average Ease of Use |
|
| 5 = Easiest to Use |
|