BioVentrix Revivent TC™ System Clinical Study

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 clinical centers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02931240
Study type	Interventional
Source	BioVentrix
Contact
Status	Active, not recruiting
Phase	N/A
Start date	August 29, 2017
Completion date	June 30, 2027

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