Status:
WITHDRAWN
The Destination Therapy Evaluation for Failing Fontan Study
Lead Sponsor:
Timothy Icenogle, MD
Conditions:
Failing Fontan Physiology
Failing Fontan
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Purpose: The purpose of the Destination Therapy Evaluation for Failing Fontan Study (DEFINe Study) is to perform a single center physician-investigator led feasibility study to initiate examination of...
Detailed Description
Study Design: This is a single center nonrandomized observational study led by the PI. However, patients will be recruited from other centers to participate in this trial. The recruited patients will...
Eligibility Criteria
Inclusion
- 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:
- A history of a progressive downhill course manifested by a restricted quality of life, or increasing hospital admissions, or increasing medication requirements
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01149603
Start Date
July 1 2010
End Date
September 19 2017
Last Update
September 21 2017
Active Locations (1)
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1
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204