Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UCLA UCSF
Dates
study started
study ends around

Description

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.

Official Title

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)

Details

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.

Keywords

Ventricular Dysfunction, Left, Ventricular Dysfunction, Left Ventricular Dysfunction, Revivent TC

Eligibility

Locations

  • Ronald Regan UCLA Medical Center
    Los Angeles California 90024 United States
  • University of California, San Francisco
    San Francisco California 94143 United States
  • Los Robles Hospital & Medical Center
    Thousand Oaks California 91360 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioVentrix
ID
NCT02931240
Study Type
Interventional
Participants
Expecting 126 study participants
Last Updated