Respiration Patterns With Impedance in LINQ

NCT ID: NCT02828735

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-30
• Study Completion Date: 2017-11-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Respiration assessment

Group Type: OTHER

respiration assessment

Intervention Type: DEVICE

Respiration Breathing Exercise

Interventions

respiration assessment

Respiration Breathing Exercise

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic BRC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mpiko Ntsekhe

Role: PRINCIPAL_INVESTIGATOR

Groote Schuur Hospital, Cape Town, South Africa

Locations

Groote Schuur Hospital

Cape Town, , South Africa

Countries

South Africa

Other Identifiers

EPIQ

Identifier Type: -

Identifier Source: org_study_id