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

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ClinicalTrials.gov Identifier: NCT02170363
Recruitment Status : Active, not recruiting
First Posted : June 23, 2014
Results First Posted : February 15, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Center for Life Sciences
Emergo
KCRI
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE June 19, 2014
First Posted Date  ICMJE June 23, 2014
Results First Submitted Date  ICMJE April 21, 2017
Results First Posted Date  ICMJE February 15, 2018
Last Update Posted Date January 30, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
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 the Seattle Heart Failure Model (SHFM) estimated survival with medical therapy.
Change History Complete list of historical versions of study NCT02170363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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.
  • 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.
  • 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
  • All Adverse Events [ Time Frame: As they occurred, Baseline through 180 Days ]
    Frequency of pre-defined anticipated adverse events
  • 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
  • Reoperations [ Time Frame: As they occurred, Baseline through 180 Days ]
    Frequency of reoperations
  • Rehospitalizations [ Time Frame: As they occurred, Baseline through 180 Days ]
    Frequency and incidence of rehospitalizations
  • Stroke Free Survival [ Time Frame: 6 months ]
    Percentage of participants free of debilitating stroke (Modified Rankin Score > 3)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HeartMate 3™ CE Mark Clinical Investigation Plan
Official Title  ICMJE HeartMate 3™ CE Mark Clinical Investigation Plan
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Refractory Left Ventricular Heart Failure
Intervention  ICMJE Device: Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Study Arms  ICMJE Experimental: HeartMate 3
Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
Intervention: Device: Left Ventricular Assist System (LVAS)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan,   Australia,   Austria,   Canada,   Czechia,   Germany
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02170363
Other Study ID Numbers  ICMJE TC02212014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE
  • Center for Life Sciences
  • Emergo
  • KCRI
  • Thoratec Corporation
Investigators  ICMJE
Study Director: Laura Damme, RN,MPH Thoratec Corporation
PRS Account Abbott Medical Devices
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP