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BiVACOR Total Artificial Heart Early Feasibility Study for Severe Heart Failure

This study is looking into the BiVACOR Total Artificial Heart (TAH) System for adults (ages 18-70) with severe heart failure, specifically when both sides of the heart are failing (biventricular failure) or when a common heart pump (LVAD) isn't suitable. The BiVACOR TAH System is an implantable pump designed to replace your diseased heart, using magnetic technology for durability. The goal is to see if this device is safe and works well enough to support you until a heart transplant can happen. The study plans to enroll 5 participants.

Study design
This is an interventional study, meaning participants will receive the BiVACOR TAH System. It plans to enroll 5 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be checked for 6 months, and the feasibility of the device will be assessed at 6 months or until a heart transplant, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06174103

BiVACOR® Total Artificial Heart Early Feasibility Study

Recruiting
NAAges 18–70InterventionalDevice feasibility
BiVACOR Inc.
~5 participants
Updated 2024-07-16 on ClinicalTrials.gov
What's tested:BiVACOR TAH System

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility Endpoint
Measured over 6 months or time of heart transplant (if prior to 6 months post pump implant)
+1 more outcome measured

Conditions

Heart Failure
Biventricular Failure

Explore related trials

Biventricular Heart FailureHeart Failure

NCT06174103

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner - University Medical Center Phoenix

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Duke University Hospital

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Texas Heart Institute / Baylor St. Luke's Medical Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Dennis Kirven
[email protected]
804-461-1299
Email the study team

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Eligibility criteria

Inclusion

Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines or has univentricular heart failure in which LVAD support is not recommended. ISHLT Guidelines for Biventricular Support:
Patient is categorized as INTERMACS Patient Profile Classification 2 or 3.
Patient is classified as NYHA Class IV.
Patient has a left ventricular ejection fraction (LVEF) ≤ 25%, with the exception of patients with restrictive or constrictive physiology.
Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 L/min/m2 without inotropes if inotropes are contraindicated (e.g., restrictive or constrictive heart failure), and meets one of the following criteria:
Patient is eligible for cardiac transplantation as determined by the implanting center.
Patient has adequate room in the chest as determined by 3-D imaging or other standard clinical assessments.
Patient has read and understands the informed consent form (ICF) and has voluntarily provided informed consent.

Exclusion

Patient has contraindications to anticoagulation or antiplatelet therapies.
Patient has coagulopathy defined by a platelet count \< 50 k/µl.
Patient has insufficient space in the chest to accommodate the BiVACOR pump.
Patient has a body mass index (BMI) ≥ 35 kg/m2.
Patient is highly pre-sensitized prior to pump implantation.
Patient is unconscious and unresponsive.
Patient is on pre-implant extracorporeal membrane oxygenation (ECMO) for \> 7 days.
Patient is on pre-implant temporary MCSD for more than 21 days \[e.g., Intra-aortic balloon pump (IABP), Impella, CentriMag, etc.\] unless ambulatory and free from adverse effects associated with the MCSD.
Patient is implanted with durable mechanical circulatory support (LVAD or RVAD).
Patient experienced cerebrovascular accident (CVA) within three months of eligibility evaluation.
Patient has severe end-organ dysfunction as evidenced by:
Patient has severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen.
Patient has primary pulmonary hypertension ≥ 8 Wood units.
Patient has severe systemic light-chain amyloidosis.
Patient has been diagnosed with severe cardiac cachexia or irreversible frailty.
Patient has diabetes with advanced diabetic neuropathy with accompanying skin ulceration.
Patient has a blood-borne infection within seven days of eligibility evaluation. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.
Patient is pregnant or planning pregnancy.
Patient has a co-morbidity or illness that would limit survival to less than two years.
Patient has a current drug and/or alcohol addiction or known substance abuse.
Patient has insufficient social support or a history of non-compliance with medical instructions as determined by the Investigator.
Patient is participating in another clinical trial that may impact or confound the results of the BiVACOR TAH EFS.

What this trial measures

  • Feasibility Endpoint6 months or time of heart transplant (if prior to 6 months post pump implant)

    Survival on the original BiVACOR pump

  • Safety EndpointThrough 6 months

    Evaluation of the safety of the BiVACOR TAH System using INTERMACS adverse event (AE) terms and definitions (INTERMACS Manual of Operations Version 5).