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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rxâ„¢ loop recorder with the Medtronic Reveal LINQâ„¢ loop recorder.
Implantable cardiac monitor (ICM) is an invaluable tool for diagnosing cardiac arrhythmia (1). Cryptogenic stroke, unexplained syncope and arrhythmia diagnosis are the most common indication for long term cardiac monitoring device. (2, 3). Reveal LINQTM (Medtronic, Inc.) is widely used for all of these purposes in the country. We have previously reported the use of Reveal XT in the use of atrial fibrillation (AF) surveillance in patient's post-AF ablation (2). We indicated that ICM is useful in long term monitoring of atrial arrhythmia in patients at risk of atrial fibrillation. Crystal AF (4) study also showed the importance of using ICM in detecting occult AF in patients with cryptogenic stroke in a timely manner so that appropriate treatment can be prescribed. The key to the success of ICM rest on how timely and reliable the ICM data can be transmitted to physician's office immediately after an arrhythmic events so the data can be analyzed and treatment rendered. Reveal LINQTM data transmission consists of two steps: 1. Data needs to be download into the MyCareLinkâ„¢ monitor (scheduled daily at 2 am in the morning and monitor needs to be in the within 6 feet proximity of the patient) 2. MyCareLinkâ„¢ monitor to be connected to the 3 G cellular network for the data transmission. (Fig 1). In cases of patient activated events, data transmission utilizes similar pathway.
We have reported significant delay in data transmission in the Reveal LINQTM occurs frequently and failure to connect among the Reveal LINQTM, MyCareLinkâ„¢ monitor and the cellular network is the main reason for data transmission disruption and critical data could be concealed for an extended periods. To illustrate the importance of timely transmission of patient data, a Reveal LINQTM was implanted in a 54-year-old gentle man with past medical history of recurrent syncope. On 8/12/2017 the patient developed new onset dizziness and 6 seconds sinus pause was recorded by the device. However, a connection problem of MyCarelinkTM system made data unavailable until next scheduled office visit on 11/15/2017. The physician was notified on the same day and a pacemaker was implanted on the following day, almost 3 months after his significant arrhythmic events.
The newer generation of ICM such as Confirm Rxâ„¢ (Abbott, Inc) is connected directly to a patient's existing smartphone using the Bluetooth technology. By allowing patients to record and transmit symptoms with the mobile app, Confirm Rxâ„¢ ICM brings continuous remote monitoring to patients without the need for a home-based monitor (Fig 2). It is unclear which technologies offers faster and more reliable transmission of critical patient information to physician office so timely treatment can be provided. We therefore propose a pilot randomized study comparing Confirm Rxâ„¢ and Reveal LINQTM in the reliability and timeliness in data transmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abbott, Inc Confirm Rxâ„¢ | Active Comparator | Every other consenting subject will receive the Abbott Inc. Confirm Rxâ„¢ device. |
|
| Medtronic, Inc Reveal LINQTM | Active Comparator | Every other consenting subject will receive the Medtronic, Inc. Reveal LINQTM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott, Inc Confirm Rxâ„¢ versus Medtronic, Inc Reveal LINQTM | Device | Comparing reliability and timeliness in data transmission between two implantable cardiac monitors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from arrhythmic events to time of physician notification | 12 months | |
| Time from activated events to time of physician notification | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from arrhythmic events to time of intervention if any | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John H Ip, MD | Sparrow Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States | ||
| Munson Medical Center |
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| Traverse City |
| Michigan |
| 49684 |
| United States |
| ID | Term |
|---|---|
| D013575 | Syncope |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D013610 | Tachycardia |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D000075224 | Cardiac Conduction System Disease |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
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