MOMENTUM 3 Continued Access Protocol

Advanced Refractory Left Ventricular Heart Failure Clinical Trial

— MOMENTUM 3 CAP  

Official title:

Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892955
• Other study ID #: MOMENTUM 3 CAP
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 2021

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1685
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Refractory Left Ventricular Heart Failure
• Heart Failure

Intervention

Device:
• HeartMate 3 LVAS
Implantation of HeartMate 3 LVAD 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 MOMENTUM 3 IDE Study.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Johns Hopkins Unversity Hospital	Baltimore	Maryland
United States	Cedars Sinai Medical Center	Beverly Hills	California
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Shands Hospital @ University of Florida	Gainesville	Florida
United States	Spectrum Health Butterworth Hospital	Grand Rapids	Michigan
United States	Hershey	Hershey	Pennsylvania
United States	Memorial Hermann Health Systems	Houston	Texas
United States	Methodist Houston	Houston	Texas
United States	Texas Heart Institute	Houston	Texas
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 California, San Diego	La Jolla	California
United States	University of Kentucky - Saha Cardiovascular Research Center	Lexington	Kentucky
United States	Baptist Health Medical Center - Little Rock	Little Rock	Arkansas
United States	Jewish Hospital	Louisville	Kentucky
United States	University of Wisconsin Hospitals and Clinics	Madison	Wisconsin
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota
United States	St. Thomas West Hospital	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Bon Secours St. Mary's Hospital	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	Sutter Memorial Hospital	Sacramento	California
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Stanford University	Stanford	California
United States	Tampa General Hospital	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. Review. — View 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 st — View Citation

Netuka I, Kvasnicka T, Kvasnicka J, Hrachovinová I, Ivák P, Marecek F, Bílková J, Malíková I, Jancová M, Malý 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-Free Survival	Survival at 24 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device	Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Secondary	Pump Replacement	Frequency of HeartMate 3 pump replacement at 24 months.	As they occur up to 24 months or to outcome, whichever occurs first
Secondary	Six Minute Walk Test (6MWT)	Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.	Baseline, 6 months and 24 months
Secondary	New York Heart Association (NYHA) Classification	Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.	Baseline, 6 months and 24 months
Secondary	EuroQol-5D-5L Visual Analogue Scale	Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.	Baseline, 6 months and 24 months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.	Baseline, 6 months and 24 months
Secondary	Rehospitalizations	Rate of all cause rehospitalization	From initial discharge to 2 years post-implant
Secondary	Adverse Event Rates	Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol	2 years post-implant