Refractory Heart FailureBRIOLIFENCT07252531
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
A study testing LVAD implantation in people with Refractory Heart Failure and Cardiovascular Diseases (CVD), run by BrioHealth BV at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Heart Failure, Cardiovascular Diseases (CVD)
- What is being tested?
- LVAD implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jun 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 32Show fewer
- 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.
- Patient has an uncontrolled systemic infection.
- Patient has a positive COVID 19 test within 21 days of study enrollment and at least one high risk feature including need for supplemental oxygen or ferritin >1000 ug/L.
- Patient has severe end-organ dysfunction as evidenced by one or more of the following criteria:
- Total bilirubin > 3.0 mg/dL or cirrhosis confirmed by liver imaging or hemodynamic assessment with or without biopsy confirmation.
- International normalized ratio (INR) ≥ 2.0 or PTT > 2.5 times control that is not related to anticoagulation therapy.
- Glomerular filtration rate (GFR) < 30 mL/ min/1.73 m2 or need for renal replacement therapy.
- Severe pulmonary arterial hypertension with a pulmonary vascular resistance (PVR) ≥ 8 Wood units that is not acutely reversible with pharmacologic intervention.
- Severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen or an FEV1/FVC < 0.7 and FEV1 < 40% predicted.
- Mechanical ventilation for more than three days present at the time of study enrollment.
- Documented history of pulmonary embolism or pulmonary infarct within 60 days of study enrollment.
- History of stroke within 90 days of study enrollment or history of stroke with a mRS ≥ 3 at the time of study enrollment.
- Symptomatic cerebrovascular disease and/or uncorrected carotid stenosis > 80%.
- Significant peripheral vascular disease (PVD) accompanied by pain at rest or extremity ulceration.
- Pre-albumin < 15 mg/dL and/or albumin < 2.5 g/dL.
- Patient has a non-cardiac comorbidity or illness that would limit survival to less than two years.
- Patient has a psychiatric disease or disorder, or irreversible cognitive dysfunction, and/or insufficient social support or a history of non-adherence with medical instructions that is likely to impair study compliance.
- Patient is participating in an interventional clinical trial that may impact or confound the results of the BrioVAD Trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam
Jolanda Kluin, MD, PhD, +31107035411, j.kluin@erasmusmc.nl
- Recruiting
University Medical Centrer Utrecht
Utrecht
Faiz Ramjankhan, MD, +31887556179, F.Ramjankhan@umcutrecht.nl
About this study
Official title: European Investigation of the BrioVAD Left Ventricular Assist System for the Treatment of Refractory Left Ventricular Heart Failure
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.
Read the 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.
- Being tested
- LVAD implantation
- Keywords
- BrioVAD System, Left Ventricular Assist Device
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVAD implantationDevice
Implantation of an LVAD in the chest
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Device: LVAD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate at 6 months
Measured: From enrollment to 6 months on device support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrioHealth BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial SrL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252531
- Sponsor's protocol ID
- DOC-04930
- Acronym
- BRIOLIFE
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Investigation of the BrioVAD Left Ventricular Assist System for the Treatment of Refractory Left Ventricular Heart Failure
- ClinicalTrials.gov ID
- NCT07252531
- Acronym / sponsor ID
- BRIOLIFE / DOC-04930
- Keywords
- BrioVAD System, Left Ventricular Assist Device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BrioHealth BVIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial SrL
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: LVAD implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVAD implantationImplantation of an LVAD in the chest | Device | Treatment group |
Primary outcome
Survival rate at 6 months
Time frame: From enrollment to 6 months on device support
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Refractory Heart Failure
Active, not recruiting
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Cardiovascular Diseases, Heart Diseases
Active, not recruitingPhase 4
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Heart Failure
Recruiting
Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure
Right Heart Failure
Recruiting
Corheart 6 LVAS Study
Refractory Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVAD implantation in people with Refractory Heart Failure and Cardiovascular Diseases (CVD), run by BrioHealth BV at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piet Jansen, MD, PhD (+31644046783, piet.jansen@briohealthtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate at 6 months (time frame: From enrollment to 6 months on device support). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.