Status:
COMPLETED
Reveal LINQ Respiration Clinical Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Respiratory Rate
Eligibility:
All Genders
55+ years
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 St...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04506684
Start Date
September 25 2020
End Date
July 31 2021
Last Update
December 18 2023
Active Locations (4)
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1
Cardiac Arrhythmia Service
Boca Raton, Florida, United States, 33432
2
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States, 56303
3
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States, 73120
4
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138