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The LINQ™ Respiration study will collect and characterize Reveal LINQ™ derived respiration data from patients undergoing a simulated 24-hour time period while being monitored with capnography.
The Reveal LINQ™ Respiration study is a Non-Significant Risk IDE, observational, non-randomized, multi-center, clinical study. The study is expected to be conducted at up to 5 centers in the United States and up to 100 subjects will be enrolled, with no more than 25 subjects enrolled per site. In addition, a minimum of 30% of all enrolled subjects will have a history of heart failure.
All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware downloaded onto their implanted Reveal LINQ device, Holter monitor and capnography monitor applied and undergo a series of activity and breathing maneuvers. The expected duration of subject participation in the study (from start of study procedures to study exit) is approximately 1.5 hours. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 3 months.
All Adverse events will be collected throughout the study duration of a subject's participation in the study, beginning at the time of informed consent.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational RAMware downloaded onto Reveal LINQ device | Device | The study is utilizing an investigational RAMware, either LINQ HF or ALLEVIATE-HF, that will be downloaded onto the subject's market-released Medtronic Reveal LINQ ICM. The investigational RAMware enables the hardware to record and store additional sensor data from which a respiratory rate will be derived. |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrating an agreement between LINQ and capnography derived respiratory rate | The primary objective is to demonstrate an acceptable agreement between Reveal LINQ™ derived respiratory rate and capnography waveform-derived respiratory rate. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterizing the agreement between LINQ and capnography derived respiratory rate | The secondary objective is to characterize the agreement between Reveal LINQ™ derived respiratory rate with capnography waveform-derived respiratory rate utilizing all paired measurements captured during the study protocol. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The target population for the LINQ Respiration study will include subjects who are ≥ 55 years old and implanted with a Reveal LINQ device for ≥60 days and no longer than 3 years. In addition, a minimum of 30% of all enrolled subjects will have a documented history of heart failure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Arrhythmia Service | Boca Raton | Florida | 33432 | United States | ||
| CentraCare Heart & Vascular Center |
No plan to share IPD
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| Saint Cloud |
| Minnesota |
| 56303 |
| United States |
| Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma | 73120 | United States |
| The Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |