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CompletedNCT02828735EPIQUpdated Jun 21, 2018

Respiration Patterns With Impedance in LINQ

An interventional study of respiration assessment in Breathing Exercises, sponsored by Medtronic BRC. Completed at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-21.

Sponsored by Medtronic BRC · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breathing Exercises
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 215 are open to participants now.

This study's enrollment of 20 is below the median of 43 across 882 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Medtronic BRC is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Respiration assessment

    Device: respiration assessment

Interventions

  • Devicerespiration assessment

    Respiration Breathing Exercise

06

What researchers measure

Primary outcomes

  1. feasibility of respiration detection

    Respiratory Maneuvers and Device interrogation

    Time frame: up to 18 months

07

Study locations

1 site
  • Groote Schuur Hospital
    Cape Town, South Africa
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02828735
Lead sponsor
Medtronic BRC
Responsible party
Sponsor
First posted
Jul 12, 2016
Start date
Jan 30, 2017
Primary completion
Nov 20, 2017
Completion
Nov 20, 2017
Last update
Jun 21, 2018

Study contacts

Mpiko Ntsekhe
principal investigator · Groote Schuur Hospital, Cape Town, South Africa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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