The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Surgical procedure
Tampa General Hospital
Tampa, Florida, United States
Jewish Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Success is defined as any one of the following: survival to cardiac transplantation prior to 180 days, survival on device to 180 days, device removal for recovery and survival to 60 days after device removal
Time frame: 6 months
Survival to transplant
Time frame: 6 months
Survival 30 days post-transplant
Time frame: 6 months
Survival while on device
Time frame: 6 months
Incidence of adverse events while on device
Time frame: 6 months
Device reliability
Time frame: 6 months
Reoperations
Time frame: 6 months
Functional status
Time frame: 6 months
Quality of life
Time frame: 6 months
Neurocognitive evaluation
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Utah Hospital
Salt Lake City, Utah, United States
Inova Fairfax Hospital/Inova Heart & Vascular Institute
Falls Church, Virginia, United States