BiVACOR® Total Artificial Heart Early Feasibility Study
NCT ID: NCT06174103
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2024-06-26
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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BiVACOR TAH
The BiVACOR TAH System will be implanted as a bridge to transplant (BTT) for adults with severe irreversible biventricular heart failure or univentricular heart failure in which LVAD support is not recommended, and who are eligible for cardiac transplantation.
BiVACOR TAH System
The BiVACOR pump is an implantable rotary biventricular blood pump that uses magnetic levitation technology for increased durability to replace both ventricles of a failing heart. The device is intended to replace the diseased heart in patients suffering from heart failure to bridge the time to heart transplant.
Interventions
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BiVACOR TAH System
The BiVACOR pump is an implantable rotary biventricular blood pump that uses magnetic levitation technology for increased durability to replace both ventricles of a failing heart. The device is intended to replace the diseased heart in patients suffering from heart failure to bridge the time to heart transplant.
Eligibility Criteria
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Inclusion Criteria
1. Biventricular failure with at least two of the following hemodynamic and/or echocardiographic measurements.
1. Right ventricular ejection fraction (RVEF) ≤ 30%
2. Right ventricular stroke work index (RVSWI) ≤ 0.25 g/m/beat/m2
3. Tricuspid annular plane systolic excursion (TAPSE) ≤ 14 mm
4. Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio \> 0.72
5. Central venous pressure (CVP) \> 15mmHg
6. CVP to pulmonary capillary wedge pressure (PCWP) ratio \> 0.63
7. Tricuspid insufficiency grade 4
8. Pulmonary artery pressure index (PAPi) \< 2
2. Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
3. Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative heart disease).
* 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:
1. 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
2. Has advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support device (MCSD) for at least seven days.
* 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 Criteria
* 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:
1. Total bilirubin \> 4.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy, and/or
2. Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 or renal replacement therapy dependence.
* 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.
18 Years
70 Years
ALL
No
Sponsors
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BiVACOR Inc.
INDUSTRY
Responsible Party
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Locations
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Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Duke University Hospital
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Texas Heart Institute / Baylor St. Luke's Medical Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CP-0001
Identifier Type: -
Identifier Source: org_study_id
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