RESTAGE - HF
|Principal Investigator: CraigSelzman|
|Keywords: Heart Failure , LVAD , Left Ventricular Assist Device , Heart Recovery||Department: Cardiothoracic Divison|
|IRB Number: 00063817||Co Investigator: StavrosDrakos|
|Specialty: Cardiology, Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiology|
|Sub Specialties: Heart Failure, Cardiac Mechanical Support, Heart Failure, Echocardiography|
The primary objective of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function (remission from HF) after undergoing a standardized LVAD plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months.
The secondary objectives of this study are to determine the durability of sustained remission from HF following LVAD explantation at 12 months and up to 3 years as well as determine the predictors of recovery.
This is a non-randomized, prospective, multi-center study. Forty subjects satisfying the inclusion and exclusion criteria will be recruited at participating centers. Subjects will be recruited to the trial in a preliminary manner prior to LVAD implantation or within 4 weeks of LVAD implantation.
Subjects will be followed for up to 3 years after explantation of the device, or until heart transplantation. All participating centers will maintain a screening log of patients with cardiomyopathy undergoing LVAD implantation.
All consecutive, eligible patients to be implanted with a HeartMate II regardless of indication for use (Bridge to Transplant or Destination Therapy) will be considered for the study.
1. Subject age between 18 - 59 years, inclusive
2. Subject indicated for DT or BTT
3. Subject with severe clinical heart failure resistant to intensive medical therapy and requiring LVAD implantation
4. Subject with LVEF < 25% and cardiomegaly at the time of LVAD implantation as documented by radionuclide or contrast ventriculography or by echocardiography
5. Subject with non-ischemic etiology (confirmed by angiography either within 2 years of implantation or prior to explantation)
6. Subject have undergone HM II implantation within prior 4 weeks or planned for a HM II implant
7. Subject has a history of HF < 5 years. Timing of "duration of heart failure" should be taken as the earlier date of either the duration of any CHF symptoms or an echo recorded with EF < 40%.
Subjects will be excluded from study participation for any one or more of the following:
1. Subject has evidence of active acute myocarditis confirmed by histology
2. Subject has a history of previous CVA resulting in significant fixed motor deficit limiting ability to perform exercise testing
3. Subject has been implanted with a mechanical aortic and/or mitral valve(s)
4. Subject had an aortic valve closure
5. Subject diagnosed with a hypertrophic obstructive cardiomyopathy or sarcoidosis
6. Subject with LVEIDD below normal confirmed by surface echocardiogram (restrictive cardiomyopathy)
7. Subject has irreversible multi-organ failure
8. Pregnant or lactating women or unwilling to utilize two reliable methods of birth control for women of childbearing age
9. Subject is diagnosed with a psychiatric disease, irreversible cognitive dysfunction or poor psychosocial issues that is likely to impair compliance with the study protocol
10.Subject with any condition, other than heart failure, that could limit survival to less than 2 years
11.Subject has a history of cardiac or other organ transplant
12. Subject is contraindicated to anticoagulation/antiplatelet therapy
13.Subject requires acute or chronic renal replacement therapy (e.g. chronic dialysis) within 3 months prior to enrollment
14.Subject participating in any other clinical investigations involving another Mechanical Circulatory Support (MCS) device or heart failure related drug, or investigations which are likely to confound study results or affect study outcome.