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

Conditions

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• BrioVAD System — DEVICE
  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.
• HeartMate 3 — DEVICE
  Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.

Study Details

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.

Key Dates

Start date

Oct 28, 2024

Status verified

Mar 2026

Primary completion

Feb 29, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

780 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BrioVAD System
  BrioVAD® Left Ventricular Assist System (BrioVAD® System) by BrioHealth Solutions, Inc.
• Active Comparator: HeartMate 3
  HeartMate 3 System by Abbott

Primary Outcome Measure

Short-Term Indication Primary Endpoint [ Time Frame: 6 months ]

Central Contacts

• Pranesh Thirukkonda
  12014016539
  [email protected]
• Lynda McMahon
  15085252203
  [email protected]

Locations (37)

Find similar trials in Little Rock, AR

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