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Trial registered on ANZCTR


Registration number
ACTRN12624001379505
Ethics application status
Approved
Date submitted
23/09/2024
Date registered
20/11/2024
Date last updated
20/11/2024
Date data sharing statement initially provided
20/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
BiVACOR® Total Artificial Heart Clinical Feasibility Study (Australian Study)
Scientific title
BiVACOR® Total Artificial Heart Clinical Feasibility Study
Secondary ID [1] 312969 0
CP-0010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 335140 0
Biventricular Failure 335141 0
Condition category
Condition code
Cardiovascular 331640 331640 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BiVACOR TAH System will be used 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. The BiVACOR TAH System replaces the failing heart and provides blood flow to the lungs and to the rest of the body. The BiVACOR TAH System is comprised of multiple components including the Pump, Driveline, Controller and Console. The Pump is implanted in the chest to replace both ventricles of a failing heart. The Driveline connects the Pump to the Controller. The Controller is a computer that controls, powers, and monitors system operation of the BiVACOR Pump. The Console connects to the Controller and allows trained user to modify Pump settings, records and displays data from the Controller and monitors BiVACOR TAH System operation.

Study participants will undergo one or two surgical procedures. The first will be the implantation of the BiVACOR TAH Pump. The participants will then be supported by the BIVACOR TAH System and followed up to 24-months post pump implant, heart transplant, death or withdrawal from the study, whichever occurs first. Patients who are bridged to heart transplant will undergo a second surgical procedure, which includes the explant of the BiVACOR Pump and heart transplantation.

Cardiovascular surgeons with extensive experience in durable mechanical circulatory support system and heart transplantation will perform both surgical procedures. Cardiologists and Intensive Care Specialists will manage patient care post-operatively and for the duration of BiVACOR TAH System support.

The surgical procedures are anticipated to be approximately 6-months apart, unless a donor heart becomes available sooner. The BiVACOR Pump implant procedure will take approximately 6 to 6.5 hours and the heart transplant procedure will take approximately 4 to 6 hours.

The location/setting for this study will be a hospital site with active mechanical circulatory support device and heart transplant programs.

Cardiothoracic Surgeons and Operating Room Clinical Staff will be required to attend implant and technical training prior to performing surgical implant of the BiVACOR Pump. Additionally, proctors will attend the BiVACOR Pump implant to provide additional guidance. Timely and thorough monitoring of the study data to ensure protocol adherence will be conducted, with source document verification. Standard operating procedures and monitoring procedures have also been developed in accordance to ISO-14155 and International Conference for Harmonisation of Good Clinical Practice Guidelines (ICH GCP).

Any study site personnel carrying out protocol-related activities will receive the necessary training before starting work on the study. Training consists of, protocol training, Technical Training and Implant Training. Technical Training consists of a combination of didactic lectures and benchtop simulation. Cardiothoracic surgeons and Operating Room Clinical Staff will also undergo TAH surgical implant in a pre-clinical laboratory that is designed to provide an opportunity to review, practice, and demonstrate key techniques and approaches required to properly implant the BiVACOR Pump and transition circulatory support to the BiVACOR TAH system.

The major regional differences are that in Australia, patients will be discharged from the hospital, when it is deemed medically suitable by their treating clinical team. In the US patients are required to remain in-hospital for the duration of the study.
Intervention code [1] 329499 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339371 0
Feasibility Endpoint
Timepoint [1] 339371 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.
Primary outcome [2] 339372 0
Safety Endpoint
Timepoint [2] 339372 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.
Secondary outcome [1] 439694 0
Heart failure classification
Timepoint [1] 439694 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.
Secondary outcome [2] 439695 0
Aerobic capacity and endurance
Timepoint [2] 439695 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.
Secondary outcome [3] 440014 0
Quality of Life
Timepoint [3] 440014 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.
Secondary outcome [4] 441727 0
Quality of Life
Timepoint [4] 441727 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.
Secondary outcome [5] 441728 0
Severity of Stroke
Timepoint [5] 441728 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.
Secondary outcome [6] 441729 0
Neurologic Disability
Timepoint [6] 441729 0
6 months post pump implant, transplant, death or withdrawal from the study, whichever occurs first.

Eligibility
Key inclusion criteria
- 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:
1. Biventricular failure with at least two of the following hemodynamic and/or echocardiographic measurements.
*Right ventricular ejection fraction (RVEF) less than or equal to 30%
*Right ventricular stroke work index (RVSWI) less than or equal to 0.25 g/m/beat/m2
*Tricuspid annular plane systolic excursion (TAPSE) less than or equal to 14 mm
*Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio greater than 0.72
*Central venous pressure (CVP) greater than 15mmHg
*CVP to pulmonary capillary wedge pressure (PCWP) ratio greater than 0.63
*Tricuspid insufficiency grade 4
*Pulmonary artery pressure index (PAPi) less than 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) less than or equal to 25%, with the exception of patients with restrictive or constrictive physiology.
- Patient is inotrope dependent, OR has a cardiac index (CI) less than or equal to 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 centre.
- 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient has contraindications to anticoagulation or antiplatelet therapies.
- Patient has coagulopathy defined by a platelet count less than 50 k/µl.
- Patient has insufficient space in the chest to accommodate the BiVACOR pump.
- Patient has a body mass index (BMI) less than or equal to 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 greater than 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 greater than 4.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy, and/or
2. Glomerular filtration rate (GFR) less than 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 greater than or equal to 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Study will not have statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/11/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 27095 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 27324 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43168 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 43415 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 317401 0
Government body
Name [1] 317401 0
Medical Research Future Fund Frontiers, Department of Health and Aged Care
Country [1] 317401 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BiVACOR Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319691 0
None
Name [1] 319691 0
Address [1] 319691 0
Country [1] 319691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316126 0
Bellberry Human Research Ethics Committee C
Ethics committee address [1] 316126 0
Ethics committee country [1] 316126 0
Australia
Date submitted for ethics approval [1] 316126 0
12/06/2024
Approval date [1] 316126 0
02/08/2024
Ethics approval number [1] 316126 0
2024-06-754

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136878 0
Prof Christopher Hayward
Address 136878 0
St.Vincent Hospital, 390 Victoria Street, Darlinghurst NSW 2010
Country 136878 0
Australia
Phone 136878 0
+61 02 8382 6880
Fax 136878 0
Email 136878 0
cshayward@stvincents.com.au
Contact person for public queries
Name 136879 0
Dr Daniel Timms
Address 136879 0
BiVACOR Pty Ltd, 16 Nexus Way, Southport, QLD, 4215
Country 136879 0
Australia
Phone 136879 0
+61 438 567 330
Fax 136879 0
Email 136879 0
daniel.timms@bivacor.com
Contact person for scientific queries
Name 136880 0
Dr Daniel Timms
Address 136880 0
BiVACOR Pty Ltd, 16 Nexus Way, Southport, QLD, 4215
Country 136880 0
Australia
Phone 136880 0
+61 438 567 330
Fax 136880 0
Email 136880 0
daniel.timms@bivacor.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.