Respiratory Rate
Conditions
Keywords
Reveal LINQ device
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInvestigational RAMware downloaded onto Reveal LINQ 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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Inclusion criteria
* Patient is ≥ 55 years old * Patient (or patient's legally authorized representative) is willing and able to provide written informed consent * Patient is willing and able to comply with the study procedures * Patient has an active Medtronic Reveal LINQ device that has been implanted for ≥ 60 days and no more than 3 years
Exclusion criteria
* Patient has an existing condition that necessitates the use of supplemental oxygen * Patient has an active acute respiratory infection or a respiratory disorder that may affect ability to perform respiratory maneuvers * Patient has NYHA Class IV heart failure per most recent assessment * Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator * Patient is enrolled in another study that could confound the results of this study * Patient has an existing implantation of Medtronic IPG, ICD, CRT-D or CRT-P device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrating an agreement between LINQ and capnography derived respiratory rate | 6 months | The primary objective is to demonstrate an acceptable agreement between Reveal LINQ™ derived respiratory rate and capnography waveform-derived respiratory rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterizing the agreement between LINQ and capnography derived respiratory rate | 6 months | 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. |
Countries
United States
Outcome results
None listed