Reveal LINQ Respiration Clinical Study

NCT ID: NCT04506684

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2021-07-31

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.

Conditions

Respiratory Rate

Keywords

Reveal LINQ device

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardiac Arrhythmia Service

Boca Raton, Florida, United States

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, United States

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, United States

The Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Countries

United States

Other Identifiers

MDT20022

Identifier Type: -

Identifier Source: org_study_id