Respiration Patterns With Impedance in LINQ

NCT02828735 | Completed

• 1 other identifier: EPIQ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing Exercises

Outcome Measures

Primary Outcomes (1)

• feasibility of respiration detection

  Respiratory Maneuvers and Device interrogation

  up to 18 months

Study Arms (1)

Respiration assessment

OTHER

Device: respiration assessment

Interventions

respiration assessment DEVICE

Respiration Breathing Exercise

Respiration assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic BRC: lead

Study Sites (1)

Groote Schuur Hospital

Cape Town, South Africa

Location

Study Officials

• Mpiko Ntsekhe

  Groote Schuur Hospital, Cape Town, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 12, 2016
• Study Start: January 30, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: June 21, 2018

Record last verified: 2018-06

Locations

ZA (1)