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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Center for Life Sciences (C3TK)
Emergo Group
KCRI
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT02170363
First received: June 19, 2014
Last updated: January 4, 2016
Last verified: January 2016
  Purpose

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 Intervention
Advanced Refractory Left Ventricular Heart Failure
Device: Left Ventricular Assist System (LVAS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HeartMate 3™ CE Mark Clinical Investigation Plan

Resource links provided by NLM:


Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Survival [ Time Frame: 6 months, Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome ]
    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:
  • Quality of Life [ Time Frame: 6 months, Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome ]
    Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)

  • Six Minute Walk Test (6MWT) [ Time Frame: 6 months, Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome ]
    Functional status as measured by the Six Minute Walk Test (6MWT) and New York Heart Association (NYHA) classification

  • Adverse Events [ Time Frame: 6 months, Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome ]
    Frequency and incidence of Pre-defined anticipated Adverse event rates

  • Device Malfunctions [ Time Frame: 6 months, 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 rates

  • Reoperations [ Time Frame: 6 months, Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome ]
    Frequency and incidence of reoperations

  • Rehospitalizations [ Time Frame: 6 months, Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome ]
    Frequency and incidence of rehospitalizations

  • Stroke [ Time Frame: 6 months, Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome ]
    Survival free of debilitating stroke (Modified Rankin Score > 3)


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: November 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02170363

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
Czech Republic
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czech Republic, 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
Thoratec Corporation
Center for Life Sciences (C3TK)
Emergo Group
KCRI
Investigators
Study Director: Poornima Sood, MD, MBA Thoratec Corporation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT02170363     History of Changes
Other Study ID Numbers: TC02212014
Study First Received: June 19, 2014
Last Updated: January 4, 2016

Keywords provided by Thoratec Corporation:
Heart Failure
Ventricular Dysfunction
Cardiomyopathies
Heart Disease
Cardiovascular Disease
Heart-assist devices

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 28, 2017