European Study of the BrioVAD Heart Pump for Advanced Heart Failure

NCT07252531 | Not Yet Recruiting DMC

• 1 other identifier: DOC-04930
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Refractory Heart Failure; Cardiovascular Diseases (CVD)

Keywords

BrioVAD System; Left Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• Survival rate at 6 months

  From enrollment to 6 months on device support

Study Arms (1)

Treatment group

EXPERIMENTAL

Device: LVAD implantation

Interventions

LVAD implantation DEVICE

Implantation of an LVAD in the chest

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age.
• Patient has a body surface area (BSA) ≥ 1.2 m2.
• Patient is classified as NYHA Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.
• Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF \< 30% on inotropes or intra-aortic balloon pump (IABP).
• Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 liters/min/m2, while not on inotropes, and also meets one of the following criteria:
• Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or
• Has advanced heart failure for at least 14 days and is dependent on an IABP for at least seven days.
• Patient has provided voluntary and informed consent.
• Females of childbearing age agree to use adequate contraception and have a negative pregnancy test.

You may not qualify if:

• Patient's heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative disease), complex congenital heart disease (e.g., transposition of the great vessels), uncorrected thyroid disease, and/or pericardial disease.
• Patient had a myocardial infarction within seven days before study enrollment.
• Patient had cardiothoracic surgery within 30 days before implant.
• Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.
• Patient has contraindications to warfarin anticoagulation.
• Patient has known hypo- or hypercoagulable state \[e.g., disseminated intravascular coagulation (DIC)\], or has a positive heparin-induced thrombocytopenia (HIT) assay and positive serotonin release assay or requires use of a non-heparin alternative anticoagulation strategy for cardiopulmonary bypass in the judgement of the Investigator.
• Patient is on durable MCS (e.g., LVAD or RVAD).
• Planned need for durable or temporary RVAD support concomitant with LVAD implant.
• Patient is on any form of pre-implant temporary MCS other than isolated LVAD support with an IABP.
• Patient is on any form of pre-implant temporary MCS with a serum lactate dehydrogenase greater than 2.5 times the upper limits of normal or with plasma free hemoglobin \> 40 g/dL.
• Patient has a history of organ transplantation.
• Patient has a mechanical aortic valve that may not be converted to a bioprosthetic valve at the time of VAD implant.
• Patient has a platelet count \< 50 k/µl.
• Patient has a history of confirmed untreated abdominal aortic aneurysm (AAA) \> 5 cm in diameter.
• Patient has moderate or severe aortic insufficiency that will not be corrected during the VAD implant procedure.

Sponsors & Collaborators

• BrioHealth BV: lead
• Meditrial SrL: collaborator

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03