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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT03091959
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be greater than 18 years of age.
2. Subject must have an implanted Medtronic CRHF device (with the Optivol® and Cardiac Compass® diagnostics) for at least 1 year.
3. Subjects between 18 years and 62 years of age must have at least 1 clinical event ,such as any major medication change, IV drug therapy, hospitalization, outside home-treatment or any similar event in the past 1 year from the date of enrollment which required a Pharmacologic intervention, associated with any of the following comorbid conditions :
* Heart failure
* Chronic Obstructive Pulmonary Disease (COPD)
* Renal deficiency
* Atrial fibrillation
* Diabetes
4. Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
5. If the subject is over 62 years of age then subject can be enrolled in the study without any pre-condition of a clinical event associated with a comorbid condition.
Exclusion Criteria:
* Subject is unwilling or unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03091959
Study Brief:
Protocol Section:
NCT03091959