NCT02931240

BioVentrix Revivent TC™ System Clinical Study

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: BioVentrix · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ventricular Dysfunction, Left

Interventions

Type	Name	Description
DEVICE	Revivent TC	Treatment of LV scar

Timeline

• Start date: 2017-08-29
• Primary completion: 2023-12-31
• Completion: 2027-06-30
• First posted: 2016-10-13
• Last updated: 2023-08-22

Locations

30 sites across 4 countries: United States, Czechia, Greece, United Kingdom

Regulatory

• FDA-regulated device study