A Study to Continue to Evaluate the Safety and Clinical Performance of the MOMENTUM 3 Left Ventricle Assist System

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-007461
    NCT ID: NCT02892955
    Sponsor Protocol Number: MOMENTUM 3 CAP

About this study

The purpose of this study is to continue to evaluate the safety and clinical performance of the HeartMate MOMENTUM 3 left ventricle assist system for the treatment of advanced, refractory, left ventricular heart failure following completion of participation in the the MOMENTUM 3 IDE study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Subject or legal representative has signed Informed Consent Form (ICF)
  • Age ≥ 18 years
  • BSA ≥ 1.2 m2
  • NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
  • LVEF ≤ 25%
  • Is inotrope dependent 
  • Is not inotrope dependent, CI < 2.2 L/min/m2 while not on inotropes, and 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 is failing to respond
    • Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for at least 7 days
  • Females of child bearing age must agree to use adequate contraception

Exclusion Criteria

  • Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
  • Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
  • Existence of ongoing mechanical circulatory support (MCS) other than IABP
  • Positive pregnancy test if of childbearing potential
  • Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant
  • History of any organ transplant
  • Platelet count < 100,000 x 103/L (< 100,000/ml)
  • Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
  • History of confirmed, untreated Abdominal Aortic Aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
  • Presence of an active, uncontrolled infection
  • Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the investigator will require based upon the patients' health status
  • 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
  • Has moderate to severe aortic insufficiency without plans for correction during pump implant
  • 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)
  • Planned Bi-VAD support prior to enrollment
  • Has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
  • Participation in any other clinical investigation that is likely to confound study results or affect the study
  • Any condition other than HF that could limit survival to less than 24 months

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Stulak, M.D.

Open for enrollment

Contact information:

June Kendall Thomas

(507)255-9053

KendallThomas.June15@mayo.edu

.
CLS-20265563

Mayo Clinic Footer