Heart Failure Clinical Trial
MOMENTUM 3 Continued Access Protocol
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.
Full Description
Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.
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%
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,
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
Patient 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
Patient 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
Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 67 Locations for this study
Little Rock Arkansas, 72205, United States
Beverly Hills California, 90211, United States
La Jolla California, 92037, United States
Sacramento California, 95816, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20010, United States
Gainesville Florida, 32610, United States
Orlando Florida, 32804, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Oak Lawn Illinois, 60453, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
Iowa City Iowa, 52242, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02214, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 63198, United States
Newark New Jersey, 07112, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28206, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73112, United States
Portland Oregon, 97239, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15323, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Charlottesville Virginia, 22908, United States
Falls Church Virginia, 22042, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23226, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98195, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53215, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.