Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : November 20, 2019
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE August 21, 2014
First Posted Date  ICMJE August 25, 2014
Results First Submitted Date  ICMJE October 2, 2019
Results First Posted Date  ICMJE November 20, 2019
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE September 2, 2014
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
  • Short Term Survival [ Time Frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first. ]
    Composite of Survival to transplant, recovery or 6 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump, HM II used as control
  • Long Term Survival [ Time Frame: The first 366 Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]
    Composite of Survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump, HM II used as control
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Rehospitalizations [ Time Frame: From initial discharge to two years post-implant ]
    Rate of all cause rehospitalization
  • Adverse Event Rates [ Time Frame: Two years post-implant ]
    Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
  • EuroQoL 5D-5L (EQ-5D-5L) [ Time Frame: Baseline and Months 1, 3, 6, 12, 18 and 24 ]
    Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline and Months 3, 6, 12, 18 and 24 ]
    Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Six Minute Walk Test (6MWT) [ Time Frame: Baseline and Months 1, 3, 6, 12, 18 and 24 ]
    Functional status as measured by the Six Minute Walk Test (6MWT) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • NYHA [ Time Frame: Baseline, Discharge, and Months 1, 3, 6, 12, 18 and 24 ]
    Functional status as measured by NYHA classification will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Reoperations [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of all reoperations will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Rehospitalizations [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of all rehospitalizations will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Device Malfunctions [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of device malfunctions will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Bleeding [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of all bleeding events will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Cardiac Arrhythmias [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of all Cardiac Arrhythmias will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Pericardial Fluid Collection [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Pericardial Fluid Collection will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Device Thrombosis [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Device Thrombosis will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Hemolysis [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Hemolysis will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Hepatic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Hepatic Dysfunction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Hypertension [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Hypertension will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Major Infection [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Major Infection will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Myocardial Infarction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Myocardial Infarction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Neurologic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Neurologic Dysfunction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Psychiatric Episode [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Psychiatric Episode will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Renal Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Renal Dysfunction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Respiratory Failure [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Respiratory Failure will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Right Heart Failure [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Right Heart Failure will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Arterial Non-CNS Thromboembolism [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Arterial Non-CNS Thromboembolism will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Venous Thromboembolism Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Venous Thromboembolism Event will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Wound Dehiscence [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Wound Dehiscence will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
  • Other Adverse Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Other Adverse Events that cause clinically relevant changes in the Subject's health (e.g. cancer) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 21, 2014)
Pump Replacement [ 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. HM II is the comparator
 
Descriptive Information
Brief Title  ICMJE MOMENTUM 3 IDE Clinical Study Protocol
Official Title  ICMJE Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Refractory Left Ventricular Heart Failure
Intervention  ICMJE
  • 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
  • Device: HeartMate II LVAS
    Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure
Study Arms  ICMJE
  • 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.
    Intervention: Device: HeartMate 3 LVAS
  • 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.
    Intervention: Device: HeartMate II 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 Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2014)
1028
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 26, 2019
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02224755
Other Study ID Numbers  ICMJE TC03062014
Has Data Monitoring Committee Yes
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 Thoratec Corporation
Investigators  ICMJE
Study Director: Poornima Sood, MD, MBA Abbott Medical Devices
PRS Account Abbott Medical Devices
Verification Date June 2019

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