Respiration Patterns With Impedance in LINQ

NCT02828735 — Not applicable, Completed, 20 participants, Medtronic BRC

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor

Registry	NCT02828735, acronym EPIQ
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	20 (Actual)
Sponsor	Medtronic BRC (Industry)
Conditions	Breathing Exercises
Interventions	respiration assessment (Device)
Dates	start 2017-01-30, primary completion 2017-11-20, completion 2017-11-20, first posted 2016-07-12, last updated 2018-06-21
Locations	1 site in South Africa

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Respiration assessment	Other	Device: respiration assessment

respiration assessment (Device): Respiration Breathing Exercise

+Outcome measures

Primary outcomes

feasibility of respiration detection [up to 18 months]: Respiratory Maneuvers and Device interrogation

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Groote Schuur Hospital	Cape Town	South Africa

+Investigators

Mpiko Ntsekhe, Principal investigator, Groote Schuur Hospital, Cape Town, South Africa