MOMENTUM 3 IDE Clinical Study Protocol

Completed · Not applicable

Conditions studied: Advanced Refractory Left Ventricular Heart Failure

In brief

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Key facts

Study ID

NCT02224755

Run by

Abbott Medical Devices

People needed

1028

Starts

2014-09-02

Expected to finish

2019-03-26

Last updated by the study team

2022-06-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Etiology of heart failure (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 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 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 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 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

Where it is running

• Cedars Sinai Medical Center — Beverly Hills, California, United States
• University of California, San Diego — La Jolla, California, United States
• Sutter Memorial Hospital — Sacramento, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Shands Hospital @ University of Florida — Gainesville, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• IU Health/Methodist Hospital — Indianapolis, Indiana, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucky - Saha Cardiovascular Research Center — Lexington, Kentucky, United States
• Jewish Hospital — Louisville, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Johns Hopkins Unversity Hospital — Baltimore, Maryland, United States
• Baptist Health Medical Center - Little Rock — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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