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MOMENTUM 3 Continued Access Protocol (MOMENTUM 3 CAP)

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: NCT02892955
Recruitment Status : Completed
First Posted : September 8, 2016
Results First Posted : March 3, 2022
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.

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

Detailed Description:
Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1685 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up
Actual Study Start Date : August 2016
Actual Primary Completion Date : December 2020
Actual Study Completion Date : March 2021

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)
The study was a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.
 Device: HeartMate 3 LVAS
Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.


Outcome Measures
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Primary Outcome Measures :
  1. Event-Free Survival [ Time Frame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]
    Survival at 24 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device


Secondary Outcome Measures :
  1. Pump Replacement [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
    Frequency of HeartMate 3 pump replacement at 24 months.

  2. Six Minute Walk Test (6MWT) [ Time Frame: Baseline, 6 months and 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.

  3. New York Heart Association (NYHA) Classification [ Time Frame: Baseline, 6 months and 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.

  4. EuroQol-5D-5L Visual Analogue Scale [ Time Frame: Baseline, 6 months and 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.

  5. Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Baseline, 6 months and 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.

  6. Rehospitalizations [ Time Frame: From initial discharge to 2 years post-implant ]
    Rate of all cause rehospitalization

  7. Adverse Event Rates [ Time Frame: 2 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 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 cardiac 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 Abdominal Aortic Aneurysm (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 that 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:

    • An INR ≥ 2.0 not due to anticoagulation therapy
    • Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
    • History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
    • Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
    • History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid artery stenosis
    • Serum Creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
    • 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
  19. Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)
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): NCT02892955


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Marie-Elena Brett Abbott Medical Devices
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol and Statistical Analysis Plan  [PDF] January 14, 2019

More Information
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Publications of Results:

Other 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: NCT02892955    
Other Study ID Numbers: MOMENTUM 3 CAP
First Posted: September 8, 2016    Key Record Dates
Results First Posted: March 3, 2022
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
Heart Failure
LVAS
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