MOMENTUM 3 Continued Access Protocol

Not Recruiting

Trial ID: NCT02892955


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.

Official Title

Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up

Stanford Investigator(s)

William Hiesinger, MD
William Hiesinger, MD

Associate Professor of Cardiothoracic Surgery (Adult Cardiac Surgery)


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

   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

      - 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

      - 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)


device: HeartMate 3 LVAS

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305