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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT04755569
Eligibility Criteria:
Inclusion Criteria:
1. Patient signed and dated informed consent form
2. Male or non-pregnant female, aged 18 or older
3. Left ventricular ejection fraction of 25-45% (inclusive)
4. Diagnosed with NYHA Class III or IV heart failure
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Medically stable and with no significant mental illness in the judgement of the principal investigator
Exclusion Criteria:
1. Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry's disease, cardiac tumor)
2. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 3 months of the baseline testing visit.
3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days before the baseline testing visit, including continuous IV inotrope therapy
4. Myocardial infarction within 3 months of the baseline testing visit.
5. Undergone a CABG procedure within 3 months90 days or a PTCA procedure within 30 days of the baseline testing visit.
6. Undergone a cardiac ablation procedure within 90 days prior to consent.
7. Prior heart transplant or ventricular assist device
8. Mechanical tricuspid valve
9. Receiving cardiac resynchronization therapy (CRT) or indicated for Class I CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
10. Currently on dialysis
11. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer
12. Participating in another cardiac investigational device study at the same time
13. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed content.
14. Expected lifespan of less than 12 months from time the baseline testing visit.
15. Resting heart rate \>110 bpm at the time of the baseline testing visit
16. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
17. Subjects currently admitted to the hospital with a primary diagnosis of heart failure
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04755569
Study Brief:
Protocol Section:
NCT04755569