Remission From Stage D Heart Failure (NCT01774656) | Clinical Trial Compass
UnknownPhase 4
Remission From Stage D Heart Failure
United States40 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function after undergoing a standardized Left Ventricular Assist Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months.
Who can participate
Age range18 Years – 59 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 and requiring LVAD implantation
✓. Subject with LVEF \< 25% and cardiomegaly at the time of LVAD implantation as documented by radionuclide or contrast ventriculography or by echocardiography
✓. Subject with non-ischemic etiology (confirmed by angiography either within 2 years of implantation or prior to explantation)
✓. Subject have undergone HM II implantation within prior 4 weeks or planned for a HM II implant
✓. Subject has a history of HF \< 5 years.
Exclusion criteria
✕. Subject has evidence of active acute myocarditis confirmed by histology
✕. Subject has a history of previous CVA resulting in significant fixed motor deficit limiting 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
✕
What they're measuring
1
Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation