A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System,
with 2:1 study vs. active concurrent control group allocation ratio. This study will include
126 patients of which 84 patients will be treated with the investigational device and 42
patients will be included in an active control group.
The Revivent TC System is indicated for patients referred for surgical treatment of left
ventricular scar that is contiguous, and includes both anterior and septal components.
Primary and Secondary Effectiveness Endpoints will compare data from the patients treated
with the Revivent TC System to a control pool of patients who comply with all aspects of the
protocol except scar location and are not treated with the investigational devices but remain
on Guideline Directed Medical Therapy (GDMT). The primary safety and effectiveness endpoints
will be evaluated at 12 months post procedure. The study will be conducted at a maximum of 20
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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