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Respiration Patterns With Impedance in LINQ | Clinical Trials | Clareo Health

COMPLETEDNA

Respiration Patterns With Impedance in LINQ

REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor

NCT02828735•Medtronic BRC

Summary

The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure.
•Chronic Kidney Disease (CKD) in Stage 5 (GFR = \<15 mL/min).
•Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible).
•Willing to sign the informed consent form.
•Greater than 18 years of age.

Exclusion Criteria

•Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
•Significant respiratory diseases such as COPD or pulmonary hypertension.
•Frequent arrhythmias, including PVC's.
•Known systolic heart failure.
•Recent infection.
•Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method.
•Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc).
•Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
•Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest.
•Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes.
+1 more criteria

Locations (1)

Groote Schuur Hospital

Cape Town, South Africa

Key Dates

Start Date

January 30, 2017

Primary Completion Date

November 20, 2017

Completion Date

November 20, 2017

Last Updated

June 21, 2018

Enrollment

ACTUAL participants

Conditions

Breathing Exercises

Interventions

respiration assessment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 21, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Respiration Patterns With Impedance in LINQ

Inclusion Criteria

Exclusion Criteria

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