Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT02828735
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02828735
Study Brief:
Protocol Section:
NCT02828735