Clinical trial NCT02892955: MOMENTUM 3 Continued Access Protocol
Official title: Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Refractory Left Ventricular Heart Failure
Keywords: Heart Failure
LVAS
Ventricular Dysfunction
Cardiomyopathy
Heart Disease
Cardiovascular Disease
Heart-assist devices
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 1685
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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:

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 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:

    * 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
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)

Primary outcomes:
measure: Event-Free Survival
timeFrame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Secondary outcomes:
measure: Pump Replacement
timeFrame: As they occur up to 24 months or to outcome, whichever occurs first
measure: Six Minute Walk Test (6MWT)
timeFrame: Baseline, 6 months and 24 months
measure: New York Heart Association (NYHA) Classification
timeFrame: Baseline, 6 months and 24 months
measure: EuroQol-5D-5L Visual Analogue Scale
timeFrame: Baseline, 6 months and 24 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
timeFrame: Baseline, 6 months and 24 months
measure: Rehospitalizations
timeFrame: From initial discharge to 2 years post-implant
measure: Adverse Event Rates
timeFrame: 2 years post-implant
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Health Medical Center - Little Rock
state: Arkansas
city: Beverly Hills
country: United States
facility: Cedars Sinai Medical Center
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands Hospital @ University of Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: IU Health/Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky - Saha Cardiovascular Research Center
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Unversity Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Hershey
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas West Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Health Systems
state: Texas
city: Houston
country: United States
facility: Methodist Houston
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: Marie-Elena Brett
role: STUDY_DIRECTOR
References:
citation: Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.
citation: Uriel N, Adatya S, Mehra MR. Evolution in Mechanical Circulatory Support: Are We at the Precipice of a Disruptive Innovation? J Am Coll Cardiol. 2015 Dec 15;66(23):2590-2593. doi: 10.1016/j.jacc.2015.10.028. No abstract available.
citation: Schmitto JD, Hanke JS, Rojas SV, Avsar M, Haverich A. First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III). J Heart Lung Transplant. 2015 Jun;34(6):858-60. doi: 10.1016/j.healun.2015.03.001. Epub 2015 Mar 7. No abstract available.
citation: Netuka I, Kvasnicka T, Kvasnicka J, Hrachovinova I, Ivak P, Marecek F, Bilkova J, Malikova I, Jancova M, Maly J, Sood P, Sundareswaran KS, Connors JM, Mehra MR. Evaluation of von Willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure. J Heart Lung Transplant. 2016 Jul;35(7):860-7. doi: 10.1016/j.healun.2016.05.019. Epub 2016 May 31.
citation: Bourque K, Cotter C, Dague C, Harjes D, Dur O, Duhamel J, Spink K, Walsh K, Burke E. Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular Assist System for Hemocompatibility. ASAIO J. 2016 Jul-Aug;62(4):375-83. doi: 10.1097/MAT.0000000000000388.
citation: Hanke JS, Haverich A, Schmitto JD. Exchange of a HeartMate II left ventricular assist device with a HeartMate 3 pump. J Heart Lung Transplant. 2016 Jul;35(7):944-6. doi: 10.1016/j.healun.2016.03.013. Epub 2016 Mar 30. No abstract available.
citation: Heatley G, Sood P, Goldstein D, Uriel N, Cleveland J, Middlebrook D, Mehra MR; MOMENTUM 3 Investigators. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant. 2016 Apr;35(4):528-36. doi: 10.1016/j.healun.2016.01.021. Epub 2016 Jan 30.
citation: Schulz A, Stepanenko A, Krabatsch T. HeartMate 3 implantation via left lateral thoracotomy with outflow graft anastomosis to the descending aorta. J Heart Lung Transplant. 2016 May;35(5):690-2. doi: 10.1016/j.healun.2016.01.004. Epub 2016 Jan 15. No abstract available.
citation: Stansfield WE, Rao V. HeartMate 3: Facing the challenge of past success. J Thorac Cardiovasc Surg. 2016 Sep;152(3):683-5. doi: 10.1016/j.jtcvs.2016.04.048. Epub 2016 Apr 22. No abstract available.
citation: Takayama H. Did you like Terminator 3 better than Terminator 2? "Rise of machines" with HeartMate 3? J Thorac Cardiovasc Surg. 2016 Sep;152(3):686-7. doi: 10.1016/j.jtcvs.2016.05.044. Epub 2016 Jun 2. No abstract available.
citation: Mehra MR, Cleveland JC Jr, Uriel N, Cowger JA, Hall S, Horstmanshof D, Naka Y, Salerno CT, Chuang J, Williams C, Goldstein DJ; MOMENTUM 3 Investigators. Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants. Eur J Heart Fail. 2021 Aug;23(8):1392-1400. doi: 10.1002/ejhf.2211. Epub 2021 May 18.
citation: Vidula H, Takeda K, Estep JD, Silvestry SC, Milano C, Cleveland JC Jr, Goldstein DJ, Uriel N, Kormos RL, Dirckx N, Mehra MR. Hospitalization Patterns and Impact of a Magnetically-Levitated Left Ventricular Assist Device in the MOMENTUM 3 Trial. JACC Heart Fail. 2022 Jul;10(7):470-481. doi: 10.1016/j.jchf.2022.03.007. Epub 2022 Jun 8.
citation: Sheikh FH, Ravichandran AK, Goldstein DJ, Agarwal R, Ransom J, Bansal A, Kim G, Cleveland JC, Uriel N, Sheridan BC, Chomsky D, Patel SR, Dirckx N, Franke A, Mehra MR. Impact of Race on Clinical Outcomes After Implantation With a Fully Magnetically Levitated Left Ventricular Assist Device: An Analysis From the MOMENTUM 3 Trial. Circ Heart Fail. 2021 Oct;14(10):e008360. doi: 10.1161/CIRCHEARTFAILURE.120.008360. Epub 2021 Sep 16.