Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02170363




Registration number
NCT02170363
Ethics application status
Date submitted
19/06/2014
Date registered
23/06/2014
Date last updated
27/06/2022

Titles & IDs
Public title
HeartMate 3™ CE Mark Clinical Investigation Plan
Scientific title
HeartMate 3™ CE Mark Clinical Investigation Plan
Secondary ID [1] 0 0
TC02212014
Universal Trial Number (UTN)
Trial acronym
HM3 CE Mark
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Refractory Left Ventricular Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Left Ventricular Assist System (LVAS)

Experimental: HeartMate 3 - Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure


Treatment: Devices: Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Quality of Life (EQ-5D-5L)
Timepoint [1] 0 0
Baseline, Month 1, Month 3, Month 6
Secondary outcome [2] 0 0
Functional Status - Six Minute Walk Test (6MWT)
Timepoint [2] 0 0
Baseline, Month 1, Month 3, Month 6
Secondary outcome [3] 0 0
Functional Status - New York Heart Association (NYHA) Classification
Timepoint [3] 0 0
Baseline, Month 1, Month 3, Month 6
Secondary outcome [4] 0 0
All Adverse Events
Timepoint [4] 0 0
As they occurred, Baseline through 180 Days
Secondary outcome [5] 0 0
Device Malfunctions
Timepoint [5] 0 0
As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome
Secondary outcome [6] 0 0
Reoperations
Timepoint [6] 0 0
As they occurred, Baseline through 180 Days
Secondary outcome [7] 0 0
Rehospitalizations
Timepoint [7] 0 0
As they occurred, Baseline through 180 Days
Secondary outcome [8] 0 0
Stroke Free Survival
Timepoint [8] 0 0
6 months

Eligibility
Key inclusion criteria
1. Patient or legal representative has signed Informed Consent Form (ICF)

2. Age = 18 years

3. BSA = 1.2 m2

4. NYHA IIIB or IV OR ACC/AHA Stage D

5. LVEF = 25%

6. CI = 2.2 L/min/m2, while not on inotropes

7. Patients must also meet one of the following:

- On Optimal Medical Management (OMM), based on current heart failure practice
guidelines for at least 45 out of the last 60 days and are failing to respond,

OR

- In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on
intraaortic balloon pump (IABP) for at least 7 days,

OR

- Inotrope dependent/unable to wean from inotropes

OR

- Listed for Transplant

8. Females of child bearing age must agree to use adequate contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive
cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy

2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of
the investigator

3. Existence of ongoing mechanical circulatory support (MCS) other than IABP

4. Positive pregnancy test if of childbearing potential

5. Lactating mothers

6. Presence of mechanical aortic cardiac valve that will not be converted to a
bioprosthesis at the time of LVAD implant

7. History of any organ transplant

8. Platelet count < 100,000 x 103/L (< 100,000/ml)

9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial
issues that are likely to impair compliance with the study protocol and LVAS
management

10. History of confirmed, untreated AAA > 5 cm in diameter

11. Presence of an active, uncontrolled infection

12. Intolerance to anticoagulant or antiplatelet therapies or any other
peri/post-operative therapy the investigator will require based upon the patients'
health status

13. Presence of any one of the following risk factors for indications of severe end organ
dysfunction or failure:

1. An INR = 2.5 not due to anticoagulation therapy

2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver
cirrhosis

3. History of severe chronic obstructive pulmonary disease (COPD) defined by
FEV1/FVC < 0.7, or FEV1 <50% predicted

4. Fixed pulmonary hypertension with a most recent PVR = 8 Wood units that is
unresponsive to pharmacologic intervention

5. History of stroke within 90 days prior to enrollment, or a history of
cerebrovascular disease with significant (> 80%) carotid artery stenosis

6. Serum creatinine =221umol/L (2.5 mg/dl) or the need for chronic renal replacement
therapy

7. Significant peripheral vascular disease (PVD) accompanied by rest pain or
extremity ulceration

14. Patient has moderate to severe aortic insufficiency without plans for correction
during pump implant

15. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL)

16. Planned Bi-VAD support prior to enrollment

17. Patient has known hypo or hyper coagulable states such as disseminated intravascular
coagulation and heparin induced thrombocytopenia

18. Participation in any other clinical investigation that is likely to confound study
results or affect the study

19. Any condition other than HF that could limit survival to less than 24 months

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/03/2020
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Oeynhausen
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Germany
State/province [6] 0 0
Freiburg
Country [7] 0 0
Germany
State/province [7] 0 0
Hannover
Country [8] 0 0
Germany
State/province [8] 0 0
Leipzig
Country [9] 0 0
Kazakhstan
State/province [9] 0 0
Astana

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Center for Life Sciences
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Emergo
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
KCRI
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Thoratec Corporation
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical investigation is to evaluate the performance and safety of the
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the
HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries.
The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP
and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with
country-specific requirements, under one clinical study protocol.

This study will evaluate the performance of the HM3 LVAS, side effects and undesirable
conditions within acceptable risks and weigh them against the intended performance of HM3
LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical
Device Directive 90/385/EEC (AIMDD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02170363
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carlo Gazzola, B. Sc.
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02170363