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.

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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.

View Eligibility Criteria

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)

Study is for people with:

Heart Failure

Estimated Enrollment:

1685

Study ID:

NCT02892955

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

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There are 67 Locations for this study

See Locations Near You

Baptist Health Medical Center - Little Rock
Little Rock Arkansas, 72205, United States
Cedars Sinai Medical Center
Beverly Hills California, 90211, United States
University of California, San Diego
La Jolla California, 92037, United States
Sutter Memorial Hospital
Sacramento California, 95816, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
California Pacific Medical Center
San Francisco California, 94115, United States
Stanford University
Stanford California, 94305, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Yale New Haven Hospital
New Haven Connecticut, 06510, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Shands Hospital @ University of Florida
Gainesville Florida, 32610, United States
Florida Hospital
Orlando Florida, 32804, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Piedmont Heart Institute
Atlanta Georgia, 30309, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
IU Health/Methodist Hospital
Indianapolis Indiana, 46202, United States
St. Vincent Hospital
Indianapolis Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Kentucky - Saha Cardiovascular Research Center
Lexington Kentucky, 40536, United States
Jewish Hospital
Louisville Kentucky, 40202, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Johns Hopkins Unversity Hospital
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02214, United States
Brigham & Women's Hospital
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Spectrum Health Butterworth Hospital
Grand Rapids Michigan, 49503, United States
Abbott Northwestern Hospital
Minneapolis Minnesota, 55407, United States
University of Minnesota Medical Center, Fairview
Minneapolis Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Barnes Jewish Hospital
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 63198, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Mt. Sinai Medical Center
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Carolinas Medical Center
Charlotte North Carolina, 28206, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
INTEGRIS Baptist Medical Center
Oklahoma City Oklahoma, 73112, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Hershey
Hershey Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15323, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
St. Thomas West Hospital
Nashville Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Baylor Research Institute
Dallas Texas, 75246, United States
Memorial Hermann Health Systems
Houston Texas, 77030, United States
Methodist Houston
Houston Texas, 77030, United States
Texas Heart Institute
Houston Texas, 77030, United States
University of Utah Hospital and Clinics
Salt Lake City Utah, 84132, United States
University of Virginia Medical Center
Charlottesville Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Bon Secours St. Mary's Hospital
Richmond Virginia, 23226, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
University of Wisconsin Hospitals and Clinics
Madison Wisconsin, 53792, United States
St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1685

Study ID:

NCT02892955

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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