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MOMENTUM 3 Continued Access Protocol (MOMENTUM 3 CAP)

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ClinicalTrials.gov Identifier: NCT02892955
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Thoratec, LLC
Information provided by (Responsible Party):
St. Jude Medical

August 24, 2016
September 8, 2016
September 6, 2018
September 2016
December 2018   (Final data collection date for primary outcome measure)
  • 6 Month Survival [ Time Frame: Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first. ]
    Composite of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 6 months
  • 24 Month Survival [ Time Frame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]
    Composite of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 24 months
Same as current
Complete list of historical versions of study NCT02892955 on ClinicalTrials.gov Archive Site
  • 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 and 24 months
  • 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 and 24 months.
  • 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 and 24 months.
  • NYHA [ Time Frame: Baseline, Initial Hospital Discharge (estimated time frame 30 days), and Months 1, 3, 6, 12, 18 and 24 ]
    Functional status as measured by NYHA classification will be analyzed at 6 months and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • Device Malfunctions [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of all device malfunctions will be analyzed at 6 months and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • Neurologic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of physician evaluated Neurologic Dysfunctions, or strokes (classified by Modified Rankin Score) will be analyzed at 6 months and 24 months.
  • Psychiatric Episode [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of physician evaluated Psychiatric Episodes will be analyzed at 6 months and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • 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 and 24 months.
  • Venous Thromboembolism Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
    Frequency and incidence of Venous Thromboembolism Events will be analyzed at 6 months and 24 months.
  • 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 and 24 months.
  • 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 and 24 months
Same as current
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.
Same as current
 
MOMENTUM 3 Continued Access Protocol
MOMENTUM 3 CAP Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Refractory Left Ventricular Heart Failure
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 the MOMENTUM 3 IDE Study.
Experimental: Experimental: HeartMate 3 LVAS (HM3 LVAS)
The study will be a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.
Intervention: Device: HeartMate 3 LVAS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
500
March 2019
December 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact: Carrie Vooght carrie.vooght@abbott.com
United States
 
 
NCT02892955
MOMENTUM 3 CAP
Yes
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Thoratec, LLC
Study Director: Poornima Sood St. Jude Medical
St. Jude Medical
September 2018

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