Clinical Study of the BioVentrix Revivent TC™
Research type
Research Study
Full title
Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms
IRAS ID
219462
Contact name
Azfar Zaman
Contact email
Sponsor organisation
BioVentix, Inc.
Duration of Study in the UK
5 years, 0 months, 2 days
Research summary
A prospective, multi-center, dual-arm pivotal study 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 be maintained on guideline directed medical therapy (GDMT) and 42 patients will be included in an active control group that will be maintained on GDMT but not receive treatment with the study device.The Revivent TC System is indicated for patients suffering from symptomatic heart failure referred for surgical treatment of left ventricular antero-septal aneurysms with or scar that is contiguous, and includes both anterior and septal components. Patients will be enrolled following the inclusion/exclusion criteria and will be monitored for 5 years thereafter.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0398
Date of REC Opinion
7 Dec 2016
REC opinion
Favourable Opinion