Respiration Patterns With Impedance in LINQ (EPIQ)

REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor

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.

Study Overview

• Status: Completed
• Conditions: Breathing Exercises
• Intervention / Treatment: Device: respiration assessment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Respiration assessment	Device: respiration assessment; Respiration Breathing Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of respiration detection	Respiratory Maneuvers and Device interrogation	up to 18 months

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Principal Investigator: Mpiko Ntsekhe, Groote Schuur Hospital, Cape Town, South Africa

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: EPIQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No