Trials / Not Yet Recruiting
Not Yet RecruitingNCT07252531
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
European Investigation of the BrioVAD Left Ventricular Assist System for the Treatment of Refractory Left Ventricular Heart Failure
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- BrioHealth BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory support.
Detailed description
This clinical investigation is conducted to assess the clinical performance and safety of the BrioVAD Left Ventricular Assist System (BrioVAD System) when used for mechanical circulatory support in patients with advanced, refractory left ventricular heart failure. The BrioVAD System is a fully magnetically levitated, centrifugal-flow left ventricular assist device (LVAD) intended to provide short-term and long-term mechanical circulatory support (MCS) in patients with advanced, refractory heart failure who remain symptomatic despite optimal medical and device therapy. The BrioVAD System is intended for use both inside and outside the hospital environment. This investigation is designed as a prospective, multi-centre, single-arm, non-inferiority clinical investigation. The performance of the BrioVAD System will be evaluated against a pre-defined Objective Performance Goal (OPG) based on contemporary LVAD clinical outcomes. The primary objective is to demonstrate that the BrioVAD System provides non-inferior clinical benefit, as measured by survival free from device replacement/removal due to device malfunction at 6 months post-implant, compared with the OPG.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LVAD implantation | Implantation of an LVAD in the chest |
Timeline
- Start date
- 2026-05-15
- Primary completion
- 2027-07-31
- Completion
- 2029-01-31
- First posted
- 2025-11-26
- Last updated
- 2026-04-02
Source: ClinicalTrials.gov record NCT07252531. Inclusion in this directory is not an endorsement.