MOMENTUM 3 IDE Clinical Study Protocol (HM3™)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by St. Jude Medical
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Corporation )
ClinicalTrials.gov Identifier:
NCT02224755
First received: August 21, 2014
Last updated: May 26, 2016
Last verified: May 2016
  Purpose
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 Intervention
Advanced Refractory Left Ventricular Heart Failure
Device: HeartMate 3 LVAS
Device: HeartMate II LVAS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • EuroQoL 5D-5L (EQ-5D-5L) [ Time Frame: Baseline and Months 1, 3, 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Other Outcome Measures:
  • Pump Replacement [ Time Frame: As they occur up to 24 months or to Outcome, whichever occurs first ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 1028
Study Start Date: September 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: NCT02224755

Contacts
Contact: Lahn Fendelander, MS 781-852-8310 lfendelander@sjm.com

  Show 59 Study Locations
Sponsors and Collaborators
Thoratec Corporation
St. Jude Medical
Investigators
Study Director: Poornima Sood, MD, MBA St. Jude Medical
  More Information

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT02224755     History of Changes
Other Study ID Numbers: TC03062014 
Study First Received: August 21, 2014
Last Updated: May 26, 2016
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by St. Jude Medical:
Heart Failure
Left Ventricular Assist Device
Ventricular Dysfunction
Cardiomyopathy
Heart Disease
Cardiovascular Disease
Heart-assist devices
Thoratec Corporation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2016