Summary

for people ages 18-100 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Eric Adler

Description

Summary

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

MOMENTUM 3 CAP Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol

Details

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.

Keywords

Advanced Refractory Left Ventricular Heart Failure Heart Failure LVAS Ventricular Dysfunction Cardiomyopathy Heart Disease Cardiovascular Disease Heart-assist devices Thoratec Corporation HeartMate 3 LVAS

Eligibility

You can join if…

Open to people ages 18-100

  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:
  7. 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
  8. Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days,
  9. Females of child bearing age must agree to use adequate contraception

You CAN'T join if...

  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:
  13. An INR ≥ 2.0 not due to anticoagulation therapy
  14. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
  15. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
  16. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
  17. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid artery stenosis
  18. Serum Creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
  19. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
  20. . Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
  21. . 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)
  22. . Planned Bi-VAD support prior to enrollment
  23. . Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
  24. . Participation in any other clinical investigation that is likely to confound study results or affect the study
  25. . Any condition other than HF that could limit survival to less than 24 months
  26. . Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92037 United States
  • Sharp Memorial Hospital accepting new patients
    San Diego California 92123 United States

Lead Scientist

  • Eric Adler
    Clinical Professor, Medicine. Authored (or co-authored) 42 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
St. Jude Medical
ID
NCT02892955
Study Type
Interventional
Last Updated