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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT01149603
Eligibility Criteria:
Inclusion Criteria:
* Able to sign Informed Consent and Release of Medical Information forms
* Age greater than or equal to 18 years
* Appropriate surgical candidate for the HeartMate II LVAD
* Willing to consider treatment with the HeartMate II LVAD
* BSA greater than or equal to 1.2
* Female patients must be using adequate contraceptive methods or be unable to become pregnant (2 years post-menopausal or surgically sterilized)
* Patient has Stage D heart failure for, at least, 60 days despite optimal medical management for at least the last 60 days
* Functional limitation due to heart failure as defined by at least ONE of the following:
1. A history of a progressive downhill course manifested by a restricted quality of life, or increasing hospital admissions, or increasing medication requirements
2. Presence of protein losing enteropathy
* Ineligible for cardiac transplantation at Sacred Heart Medical Center and at least one other UNOS approved heart transplant center, in the judgment of that center's multidisciplinary transplant team
* Ability to read, understand and implement the instructions for use for the HeartMate II LVAD
Exclusion Criteria:
* Technical obstacles that pose an inordinately high surgical risk, in the judgment of the investigator
* Uncorrectable acquired coagulopathy
* Primary coagulopathy or platelet disorder, including thrombocytopenia with absolute platelet count \< 80k or active state of disseminated intravascular coagulation
* Contraindication to the administration of heparin, warfarin or anti-platelet agents
* Severe intrinsic pulmonary disease in the judgment of the investigator
* On mechanical ventilatory support and unable to be weaned
* Patient is under consideration for reparative cardiac surgery (likely to result in clinical resolution of the heart failure in the judgment of the investigator)
* Prior implantation of an assist device
* Mechanical prosthetic aortic or mitral valve that will not be converted to a bio-prosthesis at time of VAD implantation
* Moderate or severe (\>1+) aortic insufficiency as determined by echocardiogram that is not amenable to surgical repair or replacement
* Evidence of severe intrinsic hepatic disease as defined as biopsy proven liver cirrhosis with a likelihood of less than two years survival; or liver enzyme values (AST, ALT or total bilirubin) that are \> 3 times the upper limit of normal within 30 days prior to surgery, except if the result of acute heart failure decompensation as determined by the investigator
* Creatinine of \> 3.5mg/dl or any form of dialysis within 24 hours prior to surgery
* Stroke within 90 days prior to surgery, or history of cerebral vascular disease with significant (\> 80%) extra cranial or intra cranial stenosis documented by carotid doppler study or angiography, without evidence of collateral flow documented by transcranial doppler study
* Alzheimer's disease and/or impaired cognitive function, or any other form of irreversible dementia (or both) that is confirmed by a neurological exam
* Patient has evidence of an untreated abdominal aortic aneurysm ≥ 5 cm as measured by abdominal ultrasound
* Suspected or active systemic infection within 48 hours prior to surgery
* Significant peripheral vascular disease as defined by rest pain or ulceration
* Patient in whom abdominal surgery is planned
* Positive serum pregnancy test, for women of childbearing potential
* Recent history of psychiatric disease or psycho-social maladaptive behaviors (including drug or alcohol abuse) that are likely to impair compliance with the study protocol, in the judgment of the investigator
* Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial
* Patient has a condition, other than heart failure, which would limit survival to less than 2 years
* Patient is eligible for cardiac transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01149603
Study Brief:
Protocol Section:
NCT01149603