Reveal LINQ Respiration Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Rate
• Intervention / Treatment: Device: Investigational RAMware downloaded onto Reveal LINQ device

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.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Cardiac Arrhythmia Service
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital Research Foundation
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Reveal LINQ device
• Other Study ID Numbers: MDT20022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes