Respiration Patterns With Impedance in LINQ

Breathing Exercises Clinical Trial

— EPIQ  

Official title:

REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828735
• Other study ID #: EPIQ
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: November 20, 2017

Study information

• Verified date: June 2018
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breathing Exercises

Intervention

Device:
• respiration assessment
Respiration Breathing Exercise

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of respiration detection	Respiratory Maneuvers and Device interrogation	up to 18 months