Respiration Patterns With Impedance in LINQ

Not Applicable

Completed

• Conditions: Breathing Exercises
• Interventions: Device: respiration assessment

• Registration Number: NCT02828735
• Lead Sponsor: Medtronic BRC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Study Start: 2017-01-30
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.
• Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiration assessment	respiration assessment	-

Primary Outcome Measures

Name	Time	Method
feasibility of respiration detection	up to 18 months	Respiratory Maneuvers and Device interrogation

Trial Locations

Locations (1)

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa