NCT04506684

Reveal LINQ Respiration Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: —

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.

Conditions

• Respiratory Rate

Interventions

Type	Name	Description
DEVICE	Investigational 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.

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-08-10
• Last updated: 2023-12-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study