Actively Recruiting
BiVACOR® Total Artificial Heart Early Feasibility Study
Led by BiVACOR Inc. · Updated on 2024-07-16
5
Participants Needed
4
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects.
CONDITIONS
Official Title
BiVACOR® Total Artificial Heart Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has severe, irreversible biventricular heart failure eligible for biventricular mechanical support per ISHLT guidelines or univentricular heart failure where LVAD is not recommended
- Meets at least two of specified ISHLT hemodynamic or echocardiographic criteria for biventricular failure
- Has treatment-refractory ventricular tachycardia or fibrillation with untreatable arrhythmogenic substrate
- Has heart failure due to restrictive or constrictive physiology
- Classified as INTERMACS Profile 2 or 3
- Classified as NYHA Class IV
- Left ventricular ejection fraction (LVEF) of 25% or less, except restrictive/constrictive physiology
- Is dependent on inotropes or has cardiac index ≤ 2.2 L/min/m2 without inotropes if contraindicated
- On optimal medical management for at least 45 of last 60 days without adequate response or
- Has advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump or similar device for at least 7 days
- Eligible for cardiac transplantation as determined by implanting center
- Has adequate chest space determined by 3-D imaging or clinical assessment
- Has read, understands, and voluntarily consented to the informed consent form
You will not qualify if you...
- Contraindications to anticoagulation or antiplatelet therapies
- Coagulopathy with platelet count less than 50 k/µl
- Insufficient chest space for BiVACOR pump
- Body mass index (BMI) of 35 kg/m2 or greater
- Highly pre-sensitized prior to pump implantation
- Unconscious and unresponsive
- On extracorporeal membrane oxygenation (ECMO) for more than 7 days before implant
- On temporary mechanical circulatory support device for more than 21 days unless ambulatory and free of adverse effects
- Has durable mechanical circulatory support device implanted
- Experienced cerebrovascular accident within 3 months before evaluation
- Severe end-organ dysfunction (bilirubin >4.0 mg/dL or cirrhosis; glomerular filtration rate <30 mL/min/1.73 m2 or renal replacement therapy)
- Severe chronic obstructive pulmonary disease or restrictive lung disease requiring home oxygen
- Primary pulmonary hypertension ≥ 8 Wood units
- Severe systemic light-chain amyloidosis
- Severe cardiac cachexia or irreversible frailty
- Diabetes with advanced neuropathy and skin ulceration
- Blood-borne infection within 7 days before evaluation (except certain contaminants)
- Pregnant or planning pregnancy
- Co-morbidity or illness limiting survival to less than 2 years
- Current drug/alcohol addiction or known substance abuse
- Insufficient social support or history of non-compliance
- Participation in another clinical trial that may affect BiVACOR TAH results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
3
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
4
Texas Heart Institute / Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Dennis Kirven
CONTACT
D
Diane Covington
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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