Heart Failure, Congestive Clinical Trial
Official title:
Paracor Ventricular Support System: United States Clinical Investigational Plan
This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor
Ventricular Support System when used to treat patients with heart failure. The implant,
which is loaded onto the delivery system, is placed over the epicardial surface of the right
and left ventricles.
No formal hypothesis testing will be performed; descriptive statistics will be used to
summarize patient outcomes. The results of the study will be used to guide the design and
sample size estimation of future studies.
Please refer to brief summary. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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