NCT06813820

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: BioVentrix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.

Detailed description

The purpose of the study is to assess the safety and effectiveness of the BioVentrix Revivent System plus GDMT compared to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure. Safety will be assessed compared with a Performance Goal based on surgical ventriculoplasty outcomes (MAE's at 30 days).

Conditions

• Left Ventricle Remodeling
• Left Ventricle Dilated
• CHF

Interventions

Type	Name	Description
DEVICE	Revivent System	BioVentrix has developed the Revivent System to mirror Surgical Ventricular Restoration (SVR). The Revivent System is used to place permanent cardiac implants to the epicardial surface for the purpose of reconfiguring abnormal cardiac geometry that is contributing to the dysfunction.

Timeline

• Start date: 2025-09-29
• Primary completion: 2028-08-01
• Completion: 2032-08-01
• First posted: 2025-02-07
• Last updated: 2026-02-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study