Reveal LINQ Respiration Clinical Study

NCT04506684 | Completed FDA Device

• 1 other identifier: MDT20022
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 4

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.

Conditions

Respiratory Rate

Keywords

Reveal LINQ device

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Characterizing the agreement between LINQ and capnography derived respiratory rate

  6 months

Interventions

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.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (4)

Cardiac Arrhythmia Service

Boca Raton, Florida, 33432, United States

Location

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, 73120, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 25, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)