Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001036505
Ethics application status
Approved
Date submitted
25/05/2015
Date registered
6/10/2015
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Date results information initially provided
30/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Research study of a new miniaturized (reduced size) left-ventricular assist device called “Miniaturized Ventricular Assist Device“(MVAD 'Registered Trademark' System), which is being developed for the treatment of advanced heart failure.
Scientific title
Multi center, prospective, non-randomized, single-arm clinical trial evaluating the clinical safety and performance of the HeartWare MVAD 'Registered Trademark' system for the treatment of advanced heart failure (MVAD-Advantage Trial)
Secondary ID [1] 286796 0
Trial registered in ClinicalTrials.gov – ID: NCT01831544
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced heart failure 295171 0
Condition category
Condition code
Cardiovascular 295416 295416 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implants of the MVAD’Registered Trademark’ pump may be performed via a median sternotomy or lateral thoracotomy. In all cases a cardiopulmonary bypass is required. An expert from HeartWare will be present during surgery. During implantation, the pump’s integrated inflow cannula is inserted into the left ventricle and is secured to the myocardium using an adjustable sewing ring. A 10mm diameter, gel impregnated, polyester outflow graft connects the pump to a major artery. A strain relief fits over the outflow graft to prevent kinking and to secure the outflow graft to the pump housing. The percutaneous driveline connects the implanted pump to the Pal 'Trademark' Controller and power sources. The driveline is wrapped with a woven polyester fabric to encourage tissue in-growth at the skin exit site. The pump size and intraventricular inflow cannula allow for pericardial placement, eliminating the need for an abdominal pocket. Implant procedure goes between 2-4 hours. Time in situ is difficult to determine as this depends on patient condition and may vary until clinical indicated explanation is required, the patient can receive a heart transplant or it can be even indefinitely.
Intervention code [1] 291954 0
Treatment: Devices
Comparator / control treatment
There is no comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295152 0
Survival presented as a simple proportion (subjects alive on the MVAD 'Registered Trademark' pump divided by endpoint eligible subjects).
Timepoint [1] 295152 0
6 month after implant
Secondary outcome [1] 314883 0
Survival at 24 months presented as a simple proportion (subjects alive on the MVAD 'Registered Trademark' pump divided by endpoint eligible subjects)
Timepoint [1] 314883 0
24 month after implant
Secondary outcome [2] 315625 0
Overall Survival (Time to Death)
Timepoint [2] 315625 0
6 month and 24 month after implant
Secondary outcome [3] 315626 0
Incidence of major bleeding, per INTERMACS definition
Timepoint [3] 315626 0
6 month and 24 month after implant
Secondary outcome [4] 315627 0
Incidence of all device failures and device malfunctions per INTERMACS definition
Timepoint [4] 315627 0
6 month and 24 month after implant
Secondary outcome [5] 315628 0
Incidence of major infection, per INTERMACS definition
Timepoint [5] 315628 0
6 month and 24 month after implant
Secondary outcome [6] 315629 0
Incidence of neurological dysfunction per INTERMACS definition
Timepoint [6] 315629 0
6 month and 24 month after implant
Secondary outcome [7] 315630 0
Health Status change, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQol EQ-5D-5L
Timepoint [7] 315630 0
6 month and 24 month after implant
Secondary outcome [8] 315631 0
Functional status change, as measured by NYHA and 6-minute walk
Timepoint [8] 315631 0
6 month and 24 month after implant
Secondary outcome [9] 315632 0
Frequency and rates of adverse events (AEs) throughout VAD support per INTERMACS Definition
Timepoint [9] 315632 0
6 month and 24 month after implant
Secondary outcome [10] 315633 0
Length of operative time and initial hospital stay (This is a composite) - assessed through medical records
Timepoint [10] 315633 0
6 month and 24 month after implant
Secondary outcome [11] 315634 0
Re-Hospitalizations (excluding planned procedures) assessed through medical records
Timepoint [11] 315634 0
6 month and 24 month after implant
Secondary outcome [12] 315635 0
Number of Transplantations - assessed through medical records
Timepoint [12] 315635 0
6 month and 24 month after implant
Secondary outcome [13] 315636 0
Number of Explants - assessed through medical records
Timepoint [13] 315636 0
6 month and 24 month after implant

Eligibility
Key inclusion criteria
1. Must be greater than or equal to18 years of age at consent
2. Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following):
a. on optimal medical management including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or
b. in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes.
3. Left ventricular ejection fraction less than or equal to 25%.
4. Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
5. The subject has signed the informed consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Body Mass Index (BMI) > 47.
2. Body Surface Area (BSA) < 1.0 m2.
3. Partial or full mechanical circulatory support within thirty days of implant.
4. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA 'Registered Trademark'.
5. Prior cardiac transplant or cardiomyoplasty.
6. History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter > 5 cm).
7. Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities.
8. On ventilator support for > 72 hours within the four days immediately prior to implant.
9. Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan.
10. Symptomatic cerebrovascular disease, stroke within 180 days of implant or > 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation
11. Uncorrected moderate to severe aortic insufficiency.
12. Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening.
13. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.
14. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, International Normalized Ratio (INR) > 2.0 or Partial Thromboplastin Time (PTT) > 2.5 times control in the absence of anticoagulation therapy).
15. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the subject’s health status.
16. Serum creatinine > 3.0 mg/dL within 72 hours of implant or requiring dialysis.
17. Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)] > 3 times upper limit of normal within 72 hours of implant.
18. A total bilirubin > 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension.
19. Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation.
20. Subjects with a mechanical heart valve.
21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 < 50% predicted value).
23. Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial.
24. Severe illness, other than heart disease, which would limit survival to < 3 years.
25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
26. Pregnancy and breast feeding.
27. Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD.
28. Subject unwilling or unable to comply with trial requirements.
29. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
30. Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members or employees of the investigator.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
15/07/2015
Actual
15/07/2015
Date of last participant enrolment
Anticipated
Actual
21/08/2015
Date of last data collection
Anticipated
Actual
11/05/2018
Sample size
Target
60
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291338 0
Commercial sector/Industry
Name [1] 291338 0
HeartWare Inc.
Country [1] 291338 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
HeartWare Inc.
Address
14400 NW 60th Avenue
Miami Lakes, FL 33014
Country
United States of America
Secondary sponsor category [1] 290018 0
None
Name [1] 290018 0
Address [1] 290018 0
Country [1] 290018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295997 0
Ethics committee address [1] 295997 0
Ethics committee country [1] 295997 0
Date submitted for ethics approval [1] 295997 0
Approval date [1] 295997 0
23/03/2015
Ethics approval number [1] 295997 0

Summary
Brief summary
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety
and performance of the HeartWare 'Registered Trademark' Miniaturized Ventricular Assist Device (MVAD 'Registered Trademark' Pump) system
over 24 months in subjects with advanced heart failure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57558 0
Dr Paul Jansz
Address 57558 0
St Vincent's Hospital, 390 Victoria Street, Darlinghurst NSW 2010
Country 57558 0
Australia
Phone 57558 0
+ 61 2 83826871
Fax 57558 0
Email 57558 0
[email protected]
Contact person for public queries
Name 57559 0
Mr Methee Schreuder
Address 57559 0
Medtronic Bakken Research Center, Endepolsdomein 5, 6229 GW Maastricht
Country 57559 0
Netherlands
Phone 57559 0
+31611597388
Fax 57559 0
Email 57559 0
[email protected]
Contact person for scientific queries
Name 57560 0
Mr Methee Schreuder
Address 57560 0
Medtronic Bakken Research Center, Endepolsdomein 5, 6229 GW Maastricht
Country 57560 0
Netherlands
Phone 57560 0
+31611597388
Fax 57560 0
Email 57560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It was not intended to share data publically


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.