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MOMENTUM 3 IDE Clinical Study Protocol (HM3™)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02224755
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : November 20, 2019
Last Update Posted : June 27, 2022
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Condition or disease Intervention/treatment Phase
Advanced Refractory Left Ventricular Heart Failure Device: HeartMate 3 LVAS Device: HeartMate II LVAS Not Applicable

Detailed Description:
The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1028 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
Actual Study Start Date : September 2, 2014
Actual Primary Completion Date : September 28, 2018
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: HeartMate 3 LVAS (HM3 LVAS)
Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
 Device: HeartMate 3 LVAS
Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure
Active Comparator: HeartMate II LVAS
Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
 Device: HeartMate II LVAS
Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure


Outcome Measures
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Primary Outcome Measures :
  1. Short Term Primary End Point [ Time Frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first. ]
    Survival at 6 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device

  2. Long Term Primary End Point [ Time Frame: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]
    Survival at 2 years free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device


Secondary Outcome Measures :
  1. Powered Secondary End Point: Pump Replacement at Two Years [ Time Frame: As they occur up to 24 months or to Outcome, whichever occurs first ]
    In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.

  2. EuroQoL 5D-5L (EQ-5D-5L) Total Score [ Time Frame: Baseline to 24 months ]
    Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.

  3. EuroQol-5D-5L Visual Analogue Scale [ Time Frame: Baseline to 24 months ]
    Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.

  4. Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Baseline to 24 months ]
    Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.

  5. Six Minute Walk Test [ Time Frame: Baseline to 24 months ]
    Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.

  6. New York Heart Association (NYHA) Classification [ Time Frame: Baseline to 24 months ]
    Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.

  7. Rehospitalizations [ Time Frame: From initial discharge to two years post-implant ]
    Rate of all cause rehospitalization

  8. Adverse Event Rates [ Time Frame: Two years post-implant ]
    Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject or legal representative has signed Informed Consent Form (ICF)
  2. Age ≥ 18 years
  3. BSA ≥ 1.2 m2
  4. NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV
  5. LVEF ≤ 25%

  6. a) Inotrope dependent OR b) CI < 2.2 L/min/m2, while not on inotropes and subjects 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
    • Advanced Heart Failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days
  7. Females of child bearing age must agree to use adequate contraception

Exclusion Criteria:

  1. Etiology of heart failure (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. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant
  6. History of any organ transplant
  7. Platelet count < 100,000 x 103/L (< 100,000/ml)
  8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
  9. History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment
  10. Presence of an active, uncontrolled infection
  11. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status

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

    1. An INR ≥ 2.0 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, and 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%) uncorrected carotid stenosis
    6. Serum creatinine ≥ 221 umol/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
  13. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
  14. Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one available) ; pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both available)
  15. Planned Bi-VAD support prior to enrollment
  16. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
  17. Participation in any other clinical investigation that is likely to confound study results or affect the study
  18. Any condition other than HF that could limit survival to less than 24 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224755


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Thoratec Corporation
Investigators
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Study Director: Daniel Crandall, PhD Abbott
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol  [PDF] May 8, 2017
Statistical Analysis Plan  [PDF] January 22, 2016

More Information
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Publications:

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

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02224755    
Other Study ID Numbers: TC03062014
First Posted: August 25, 2014    Key Record Dates
Results First Posted: November 20, 2019
Last Update Posted: June 27, 2022
Last Verified: June 2022
Keywords provided by Abbott Medical Devices:
Heart Failure
Left Ventricular Assist Device
Ventricular Dysfunction
Cardiomyopathy
 Heart Disease
Cardiovascular Disease
Heart-assist devices
Thoratec Corporation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases