Respiration Patterns With Impedance in LINQ
|Start date||January 2017|
|End date||September 2017|
|Trial size||20 participants|
|Trial identifier||NCT02828735, EPIQ|
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.
|Intervention model||single group assignment|
feasibility of respiration detection
time frame: up to 18 months
All participants at least 18 years old.
- 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.
- 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.
|Official title||REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor|
|Principal investigator||Mpiko Ntsekhe|
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