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OpenTrials
Completed

NCT Number: NCT02828735

Respiration Patterns With Impedance in LINQ

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.

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Key information

Conditions

Breathing Exercises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groote Schuur Hospital

Cape Town, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

respiration assessment

Device

Respiration Breathing Exercise

Primary outcomes

  1. feasibility of respiration detection

    Time frame: up to 18 months

    Respiratory Maneuvers and Device interrogation

Sponsors and collaborators

Lead sponsor

Medtronic BRC

Industry

Registry information

Official study title

REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor

Acronym: EPIQ

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2016
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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