Heart Failure Clinical Trial
Official title:
Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access)
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
The purpose of this study is to allow the continued use of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure while the pivotal trial for the BioVentrix Revivent TC System is continuing through the follow up phase and the PMA documentation is prepared and reviewed by FDA. ;
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