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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT01187368
Eligibility Criteria:
Inclusion Criteria:
The following is a list of general inclusion criteria:
* Age ≥ 18 years
* Left Ventricular Ejection Fraction (LVEF) \< 30%
* NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
* Inotrope dependent OR Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes
* Patient is able to provide written informed consent
* More detailed inclusion criteria information is noted in the study protocol
Exclusion Criteria:
1. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
2. Technical obstacles which pose an inordinately high surgical risk
3. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
4. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
5. Positive pregnancy test if of childbearing potential
6. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis
7. History of any organ transplant
8. Platelet count \<100,000/mL
9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues
10. History of confirmed, untreated abdominal aortic aneurysm (AAA) \> 5 cm in diameter within 6 months of enrollment
11. Presence of an active, uncontrolled infection
12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy that the investigator will require based upon the patient's health status
13. Presence of remarkable pre-defined end-organ dysfunction.
14. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
15. Low albumin - removed from recent exclusion criteria
16. Planned Bi-VAD support prior to enrollment
17. Patient has known hypo- or hyper coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)
18. Participation in any other clinical investigation that is likely to confound study results or affect the study
19. Any condition other than heart failure that could limit survival to less than 24 months
20. Patients refusing blood transfusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01187368
Study Brief:
Protocol Section:
NCT01187368