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The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEEQ™ MCT/ECM System | SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield of the SEEQ™ MCT/ECM System | 120 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (for example, atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias, and conduction disorders.
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| Name | Affiliation | Role |
|---|---|---|
| SEEQ Performance Study Clinical Team | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Larkspur | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | SEEQ™ MCT/ECM System | SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SEEQ™ MCT/ECM System | SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. |
| 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 | Diagnostic Yield of the SEEQ™ MCT/ECM System | Subjects prescribed the SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias | Posted | Number | 95% Confidence Interval | percentage of subjects with CRA | 120 Days |
|
|
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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 | SEEQ™ MCT/ECM System | SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medtronic SEEQ Performance Clinical Trial Leader | Medtronic CRHF | 1-800-328-2518 | medtronicCRMtrials@medtronic.com |
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| Simi Valley |
| California |
| United States |
| Aurora | Colorado | United States |
| Clearwater | Florida | United States |
| Palm Beach Gardens | Florida | United States |
| Sebring | Florida | United States |
| Rome | Georgia | United States |
| Jackson | Mississippi | United States |
| Henderson | Nevada | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 182 |
| 63 |
| 182 |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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