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Hypothesis:
Patients that were previously discharged from the emergency department with a subsequent non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early Reveal LINQ™ Insertable Cardiac Monitoring System placement.
Primary Study Objectives:
To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™ Insertable Cardiac Monitoring System) in patients with suspected but no previously documented arrhythmias that result in a clinically actionable event.
Eligible patients will be enrolled after presentation to the Emergency Department of St. Elizabeth Healthcare with symptoms suggestive of cardiac arrhythmia and prior to leaving the emergency department. Patients will be exited from the study and considered complete at the identification of a cardiac arrhythmia as defined in the protocol (endpoint), or 12 months from enrollment date, whichever occurs first.
Protocol defined endpoints
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac | Other | Intensive monitoring strategy of discharging from the Emergency Department with an external 30 day cardiac monitoring system. A negative 30 day external monitor report will be followed by an implantable cardiac monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System". | Other | Intensive monitoring strategy of discharge from Emergency Department with 30 day SEEQ external monitor, followed by implantable cardiac Reveal LINQ monitor if negative 30 day result. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy. | The number of subjects in which any cardiac arrhythmia that results in a clinically actionable event will be recorded. Descriptive statistics will be used to describe baseline study subject characteristics and the clinically actionable findings. | 12 months or less |
| The total number of all significant arrhythmias detected in the study population. | To determine the total number of all significant arrhythmias detected in the study population with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and/or the implantable Reveal LINQ™ Insertable Cardiac Monitoring System. Subjects completing each phase of the intervention will be expressed as a percentage, as well as the percent of subjects with negative findings at the end of study participation. | 12 months or less |
| The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring. | Compute the average time, in days, to diagnosis of significant arrhythmia using the intensive strategy of monitoring subjects with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and the Reveal LINQ™ Insertable cardiac monitor. | 12 months or less |
| Identify and categorize arrhythmia subtypes using the intensive monitoring strategy. | Of those subjects with clinical findings, identify the action required, and categorize outcome as desirable, undesirable, or inconclusive. | 12 months or less |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if the intensive monitoring strategy causes a reduction in the number and overall expense of ancillary diagnostic testing used to aid in the detection of suspected cardiac arrhythmias. | In subjects with recurrent symptom, compare the intensive strategy to the number of prior tests that have been performed. In subject who have previously presented with symptoms and undergone prior diagnostic evaluation, estimate the total expense of all prior evaluation and diagnostic testing performed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas P Carrigan, MD, FHRS | St Elizabeth Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
Individual participant data will not be shared.
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| 12 months or less |