TARGET-LOAD Pilot Study Comparing Hemodynamics-guided LVAD Unloading Vs. Standard of Care (NCT04977310) | Clinical Trial Compass
WithdrawnNot Applicable
TARGET-LOAD Pilot Study Comparing Hemodynamics-guided LVAD Unloading Vs. Standard of Care
Stopped: Did not receive funding from sponsor
United States0Started 2025-03-31
Plain-language summary
This study is a prospective, randomized-controlled, non-blinded, multi-center, pilot trial to compare standard-of-care left ventricular assist device (LVAD) unloading plus heart failure (HF) medications reverse-remodeling management versus hemodynamics-guided LVAD unloading with use of the wireless monitoring system CardioMEMS plus HF medications reverse-remodeling management.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Severe clinical HF resistant to intensive medical therapy and requiring LVAD implantation
* Left ventricular ejection fraction \<=25% and cardiomegaly at time of LVAD implantation
* Non-ischemic etiology of HF
* Undergone LVAD implantation within prior 4 weeks or planned for LVAD implant
* History of HF \< 5 years
* Body Mass Index \<=35 kg/m\^2
* Pulmonary artery branch diameter between 7 - 15 mm
* Female subjects of childbearing age with negative urine or serum pregnancy test and agreeing to use reliable mechanical or hormonal form of contraception during study
Exclusion Criteria:
* Evidence of active acute myocarditis confirmed by histology
* History of previous cerebrovascular accident resulting in significant fixed motor deficit, limiting ability to perform exercise testing
* Implanted mechanical aortic and/or mitral valve(s) and/or right heart valve(s)
* Aortic valve closure
* Hypertrophic obstructive cardiomyopathy or sarcoidosis
* Left ventricular end-diastolic diameter below normal (restrictive cardiomyopathy)
* Irreversible multi-organ failure
* Diagnosis of psychiatric disease, irreversible cognitive dysfunction or poor psycho-social issues likely to impair compliance with study protocol
* Any condition that could limit survival to less than 2 years
* History of cardiac or other organ transplant
* Contraindicated to anti-coagulation, antiplatelet therapy, or diagnosis of coagulation disorders
* Require acute or chronic renal replacement the…
What they're measuring
1
Proportion of subjects that meet explantation criteria by month 12 post-LVAD implantation, have LVAD explanted and retain left ventricular ejection fraction >=45% at 12 months post-LVAD weaning