Phase
Condition
Chest Pain
Congestive Heart Failure
Heart Failure
Treatment
N/AClinical Study ID
Ages 18-59 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject age between 18 - 59 years, inclusive
Subject indicated for DT or BTT
Subject with severe clinical heart failure resistant to intensive medical therapy andrequiring LVAD implantation
Subject with LVEF < 25% and cardiomegaly at the time of LVAD implantation asdocumented by radionuclide or contrast ventriculography or by echocardiography
Subject with non-ischemic etiology (confirmed by angiography either within 2 years ofimplantation or prior to explantation)
Subject have undergone HM II implantation within prior 4 weeks or planned for a HM IIimplant
Subject has a history of HF < 5 years.
Exclusion
Exclusion Criteria:
Subject has evidence of active acute myocarditis confirmed by histology
Subject has a history of previous CVA resulting in significant fixed motor deficitlimiting ability to perform exercise testing
Subject has been implanted with a mechanical aortic and/or mitral valve(s)
Subject had an aortic valve closure
Subject diagnosed with a hypertrophic obstructive cardiomyopathy or sarcoidosis
Subject with LVEDD below normal confirmed by surface echocardiogram (restrictivecardiomyopathy)
Subject has irreversible multi-organ failure
Pregnant or lactating women or unwilling to utilize two reliable methods of birthcontrol for women of childbearing age
Subject is diagnosed with a psychiatric disease, irreversible cognitive dysfunction orpoor psychosocial issues that is likely to impair compliance with the study protocol
Subject with any condition, other than heart failure, that could limit survival toless than 2 years
Subject has a history of cardiac or other organ transplant
Subject is contraindicated to anticoagulation antiplatelet therapy
Subject requires acute or chronic renal replacement therapy (e.g. chronic dialysis)within 3 months prior to enrollment
Subject participating in any other clinical investigations involving anotherMechanical Circulatory Support (MCS) device or heart failure related drug, orinvestigations which are likely to confound study results or affect study outcome.
Study Design
Study Description
Connect with a study center
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
Montefiore Medical Center
New York, New York 10467
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
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