MOMENTUM 3 Continued Access Protocol (MOMENTUM 3 CAP)

• ClinicalTrials.gov Identifier: NCT02892955
• Recruitment Status: Completed
• First Posted: September 8, 2016
• Results First Posted: March 3, 2022
• Last Update Posted: June 27, 2022
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: August 24, 2016
• First Posted Date: September 8, 2016
• Results First Submitted Date: January 4, 2022
• Results First Posted Date: March 3, 2022
• Last Update Posted Date: June 27, 2022
• Actual Study Start Date: August 2016
• Actual Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2022)

Event-Free Survival [ Time Frame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]

Survival at 24 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device

Original Primary Outcome Measures (submitted: September 1, 2016)

• 6 Month Survival [ Time Frame: Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first. ]
  Composite of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 6 months
• 24 Month Survival [ Time Frame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]
  Composite of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 24 months

Current Secondary Outcome Measures (submitted: February 9, 2022)

• Pump Replacement [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
  Frequency of HeartMate 3 pump replacement at 24 months.
• Six Minute Walk Test (6MWT) [ Time Frame: Baseline, 6 months and 24 months ]
  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.
• New York Heart Association (NYHA) Classification [ Time Frame: Baseline, 6 months and 24 months ]
  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.
• EuroQol-5D-5L Visual Analogue Scale [ Time Frame: Baseline, 6 months and 24 months ]
  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.
• Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Baseline, 6 months and 24 months ]
  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.
• Rehospitalizations [ Time Frame: From initial discharge to 2 years post-implant ]
  Rate of all cause rehospitalization
• Adverse Event Rates [ Time Frame: 2 years post-implant ]
  Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol

Original Secondary Outcome Measures (submitted: September 1, 2016)

• EuroQoL 5D-5L (EQ-5D-5L) [ Time Frame: Baseline and Months 1, 3, 6, 12, 18 and 24 ]
  Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) will be analyzed at 6 months and 24 months
• Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline and Months 3, 6, 12, 18 and 24 ]
  Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) will be analyzed at 6 months and 24 months.
• Six Minute Walk Test (6MWT) [ Time Frame: Baseline and Months 1, 3, 6, 12, 18 and 24 ]
  Functional status as measured by the Six Minute Walk Test (6MWT) will be analyzed at 6 months and 24 months.
• NYHA [ Time Frame: Baseline, Initial Hospital Discharge (estimated time frame 30 days), and Months 1, 3, 6, 12, 18 and 24 ]
  Functional status as measured by NYHA classification will be analyzed at 6 months and 24 months.
• Reoperations [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of all reoperations will be analyzed at 6 months and 24 months.
• Rehospitalizations [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of all rehospitalizations will be analyzed at 6 months and 24 months.
• Device Malfunctions [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of all device malfunctions will be analyzed at 6 months and 24 months.
• Bleeding [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of all bleeding events will be analyzed at 6 months and 24 months.
• Cardiac Arrhythmias [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of all Cardiac Arrhythmias will be analyzed at 6 months and 24 months.
• Pericardial Fluid Collection [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Pericardial Fluid Collection will be analyzed at 6 months and 24 months.
• Device Thrombosis [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Device Thrombosis will be analyzed at 6 months and 24 months.
• Hemolysis [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Hemolysis will be analyzed at 6 months and 24 months.
• Hepatic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Hepatic Dysfunction will be analyzed at 6 months and 24 months.
• Hypertension [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Hypertension will be analyzed at 6 months and 24 months.
• Major Infection [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Major Infection will be analyzed at 6 months and 24 months.
• Myocardial Infarction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Myocardial Infarction will be analyzed at 6 months and 24 months.
• Neurologic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of physician evaluated Neurologic Dysfunctions, or strokes (classified by Modified Rankin Score) will be analyzed at 6 months and 24 months.
• Psychiatric Episode [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of physician evaluated Psychiatric Episodes will be analyzed at 6 months and 24 months.
• Renal Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Renal Dysfunction will be analyzed at 6 months and 24 months.
• Respiratory Failure [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Respiratory Failure will be analyzed at 6 months and 24 months.
• Right Heart Failure [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Right Heart Failure will be analyzed at 6 months and 24 months.
• Arterial Non-CNS Thromboembolism [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Arterial Non-CNS Thromboembolism will be analyzed at 6 months and 24 months.
• Venous Thromboembolism Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Venous Thromboembolism Events will be analyzed at 6 months and 24 months.
• Wound Dehiscence [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Wound Dehiscence will be analyzed at 6 months and 24 months.
• Other Adverse Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Other Adverse Events that cause clinically relevant changes in the Subject's health (e.g. cancer) will be analyzed at 6 months and 24 months

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: September 1, 2016)

Pump Replacement [ Time Frame: As they occur up to 24 months or to Outcome, whichever occurs first ]

In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months.

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Refractory Left Ventricular 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.

Study Arms

Experimental: HeartMate 3 LVAS (HM3 LVAS)

The study was a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.

Intervention: Device: HeartMate 3 LVAS

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2021): 1685
• Original Estimated Enrollment (submitted: September 1, 2016): 500
• Actual Study Completion Date: March 2021
• Actual Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02892955
• Other Study ID Numbers: MOMENTUM 3 CAP
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Same as current
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Marie-Elena Brett; Abbott Medical Devices

• PRS Account: Abbott Medical Devices
• Verification Date: June 2022