HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark)

• ClinicalTrials.gov Identifier: NCT02170363
• Recruitment Status: Completed
• First Posted: June 23, 2014
• Results First Posted: February 15, 2018
• Last Update Posted: June 27, 2022
• Sponsor: Abbott Medical Devices
• Collaborators: Center for Life Sciences; Emergo; KCRI; Thoratec Corporation
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Advanced Refractory Left Ventricular Heart Failure	Device: Left Ventricular Assist System (LVAS)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HeartMate 3™ CE Mark Clinical Investigation Plan
• Study Start Date: June 2014
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: March 9, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: HeartMate 3; Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure	Device: Left Ventricular Assist System (LVAS); Implantation of left ventricular assist device for hemodynamic support

Outcome Measures

Primary Outcome Measures :

1. Survival [ Time Frame: 6 months ]
   Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data

Secondary Outcome Measures :

1. Quality of Life (EQ-5D-5L) [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]
   The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
2. Functional Status - Six Minute Walk Test (6MWT) [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]
   The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
3. Functional Status - New York Heart Association (NYHA) Classification [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]
   NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
4. All Adverse Events [ Time Frame: As they occurred, Baseline through 180 Days ]
   Frequency of pre-defined anticipated adverse events
5. Device Malfunctions [ Time Frame: 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 ]
   Frequency and incidence of device malfunction
6. Reoperations [ Time Frame: As they occurred, Baseline through 180 Days ]
   Frequency of reoperations
7. Rehospitalizations [ Time Frame: As they occurred, Baseline through 180 Days ]
   Frequency and incidence of rehospitalizations
8. Stroke Free Survival [ Time Frame: 6 months ]
   Percentage of participants free of debilitating stroke (Modified Rankin Score > 3)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

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

Contacts and Locations

Locations

Australia, Victoria

The Alfred Hospital

Melbourne, Victoria, Australia, 3181

Austria

AKH Medical University of Vienna

Vienna, Austria, A-1090

Canada, Ontario

Toronto General Hospital

Toronto, Ontario, Canada, M5G-2C4

Czechia

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia, 4

Germany

Herz- und Diabeteszentrum NRW Thorax- und Kardiovaskularchirurgie Clinic

Bad Oeynhausen, Germany, 32545

Deutsches Herzzentrum Berlin

Berlin, Germany, 13353

Universitats-Herzzentrum Freiburg

Freiburg, Germany, 79106

Medizinische Hochschule Hannover

Hannover, Germany, 30625

Herzentrum Leipzig GmbH

Leipzig, Germany, 04280

Kazakhstan

National Research Center for Cardiac Surgery

Astana, Kazakhstan, 010000

Sponsors and Collaborators

Abbott Medical Devices

Center for Life Sciences

Emergo

KCRI

Thoratec Corporation

Investigators

• Study Director: Carlo Gazzola, B. Sc.; Abbott

More Information

Publications of Results:

Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schmitto JD, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Sood P, Damme L, Netuka I. Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study. Eur J Heart Fail. 2019 Jan;21(1):90-97. doi: 10.1002/ejhf.1284. Epub 2018 Jul 27.

Krabatsch T, Netuka I, Schmitto JD, Zimpfer D, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Damme L, Pya Y. Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial. J Cardiothorac Surg. 2017 Apr 4;12(1):23. doi: 10.1186/s13019-017-0587-3.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02170363
• Other Study ID Numbers: TC02212014
• First Posted: June 23, 2014
• Results First Posted: February 15, 2018
• Last Update Posted: June 27, 2022
• Last Verified: June 2022

Keywords provided by Abbott Medical Devices:

Heart Failure; Ventricular Dysfunction; Cardiomyopathies; Heart Disease; Cardiovascular Disease; Heart-assist devices; Thoratec Corporation

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases