NCT06310031

Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

Investigation of a Novel, magNetically Levitated VAD for the Treatment of refractOry Left Ventricular heArT failurE

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: BrioHealth Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

Detailed description

The INNOVATE Trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory left ventricular heart failure. It is the first clinical study to compare two left ventricular assist devices (LVAD) that belong to the same category of fully magnetically levitated LVAD.

Conditions

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure

Interventions

Type	Name	Description
DEVICE	BrioVAD System	Implantation of the BrioVAD System to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.
DEVICE	HeartMate 3	Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.

Timeline

• Start date: 2024-10-28
• Primary completion: 2028-02-01
• Completion: 2028-12-01
• First posted: 2024-03-13
• Last updated: 2026-04-01

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated device study