Back to resultsRespiration Patterns With Impedance in LINQ (EPIQ)
Primary Purpose
Breathing Exercises
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
respiration assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Breathing Exercises
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.
Sites / Locations
- Groote Schuur Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Respiration assessment
Arm Description
Outcomes
Primary Outcome Measures
feasibility of respiration detection
Respiratory Maneuvers and Device interrogation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02828735
Brief Title
Respiration Patterns With Impedance in LINQ
Acronym
EPIQ
Official Title
REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing Exercises
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respiration assessment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
respiration assessment
Intervention Description
Respiration Breathing Exercise
Primary Outcome Measure Information:
Title
feasibility of respiration detection
Description
Respiratory Maneuvers and Device interrogation
Time Frame
up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mpiko Ntsekhe
Organizational Affiliation
Groote Schuur Hospital, Cape Town, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groote Schuur Hospital
City
Cape Town
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Respiration Patterns With Impedance in LINQ
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