MOMENTUM 3 IDE Clinical Study Protocol (HM3™)

• ClinicalTrials.gov Identifier: NCT02224755
• Recruitment Status: Completed
• First Posted: August 25, 2014
• Results First Posted: November 20, 2019
• Last Update Posted: June 27, 2022
• Sponsor: Abbott Medical Devices
• Collaborator: Thoratec Corporation
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: August 21, 2014
• First Posted Date: August 25, 2014
• Results First Submitted Date: October 2, 2019
• Results First Posted Date: November 20, 2019
• Last Update Posted Date: June 27, 2022
• Actual Study Start Date: September 2, 2014
• Actual Primary Completion Date: September 28, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2019)

• Short Term Primary End Point [ Time Frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first. ]
  Survival at 6 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device
• Long Term Primary End Point [ Time Frame: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]
  Survival at 2 years free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device

Original Primary Outcome Measures (submitted: August 21, 2014)

• Short Term Survival [ Time Frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first. ]
  Composite of Survival to transplant, recovery or 6 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump, HM II used as control
• Long Term Survival [ Time Frame: The first 366 Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]
  Composite of Survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump, HM II used as control

Current Secondary Outcome Measures (submitted: October 30, 2019)

• Powered Secondary End Point: Pump Replacement at Two Years [ 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. HeartMate II is the control.
• EuroQoL 5D-5L (EQ-5D-5L) Total Score [ Time Frame: Baseline to 24 months ]
  Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
• EuroQol-5D-5L Visual Analogue Scale [ Time Frame: Baseline to 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 to 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.
• Six Minute Walk Test [ Time Frame: Baseline to 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 to 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.
• Rehospitalizations [ Time Frame: From initial discharge to two years post-implant ]
  Rate of all cause rehospitalization
• Adverse Event Rates [ Time Frame: Two years post-implant ]
  Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol

Original Secondary Outcome Measures (submitted: August 21, 2014)

• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• NYHA [ Time Frame: Baseline, Discharge, and Months 1, 3, 6, 12, 18 and 24 ]
  Functional status as measured by NYHA classification will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• Device Malfunctions [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of device malfunctions will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• Neurologic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Neurologic Dysfunction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• Psychiatric Episode [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Psychiatric Episode will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• Venous Thromboembolism Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]
  Frequency and incidence of Venous Thromboembolism Event will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator
• 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 (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: August 21, 2014)

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. HM II is the comparator

Descriptive Information

• Brief Title: MOMENTUM 3 IDE Clinical Study Protocol
• Official Title: Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
• Brief Summary: 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.
• Detailed Description: The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel 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 the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure
• Device: HeartMate II LVAS
  Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure

Study Arms

• Experimental: HeartMate 3 LVAS (HM3 LVAS)
  Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
  Intervention: Device: HeartMate 3 LVAS
• Active Comparator: HeartMate II LVAS
  Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
  Intervention: Device: HeartMate II LVAS

Publications *

• Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.
• Mehra MR, Goldstein DJ, Cleveland JC, Cowger JA, Hall S, Salerno CT, Naka Y, Horstmanshof D, Chuang J, Wang A, Uriel N. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022 Sep 27;328(12):1233-1242. doi: 10.1001/jama.2022.16197.
• 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.
• Lundgren SW, Florescu DF, Zolty R. Reactivation of Cytomegalovirus Following Left Ventricular Assist Device Implantation: A Case-Control Study. ASAIO J. 2021 Apr 1;67(4):405-410. doi: 10.1097/MAT.0000000000001236.
• Saeed O, Colombo PC, Mehra MR, Uriel N, Goldstein DJ, Cleveland J, Connors JM, Najjar SS, Mokadam NA, Bansal A, Crandall DL, Sood P, Jorde UP. Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study. J Heart Lung Transplant. 2020 Jun;39(6):518-525. doi: 10.1016/j.healun.2020.03.001. Epub 2020 Mar 20.
• Patel CB, Blue L, Cagliostro B, Bailey SH, Entwistle JW, John R, Thohan V, Cleveland JC Jr, Goldstein DJ, Uriel N, Su X, Somo SI, Sood P, Mehra MR. Left ventricular assist systems and infection-related outcomes: A comprehensive analysis of the MOMENTUM 3 trial. J Heart Lung Transplant. 2020 Aug;39(8):774-781. doi: 10.1016/j.healun.2020.03.002. Epub 2020 Mar 20.
• Goldstein DJ, Naka Y, Horstmanshof D, Ravichandran AK, Schroder J, Ransom J, Itoh A, Uriel N, Cleveland JC Jr, Raval NY, Cogswell R, Suarez EE, Lowes BD, Kim G, Bonde P, Sheikh FH, Sood P, Farrar DJ, Mehra MR. Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial. JAMA Cardiol. 2020 Apr 1;5(4):411-419. doi: 10.1001/jamacardio.2019.5323.
• Mehra MR, Uriel N, Naka Y, Cleveland JC Jr, Yuzefpolskaya M, Salerno CT, Walsh MN, Milano CA, Patel CB, Hutchins SW, Ransom J, Ewald GA, Itoh A, Raval NY, Silvestry SC, Cogswell R, John R, Bhimaraj A, Bruckner BA, Lowes BD, Um JY, Jeevanandam V, Sayer G, Mangi AA, Molina EJ, Sheikh F, Aaronson K, Pagani FD, Cotts WG, Tatooles AJ, Babu A, Chomsky D, Katz JN, Tessmann PB, Dean D, Krishnamoorthy A, Chuang J, Topuria I, Sood P, Goldstein DJ; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report. N Engl J Med. 2019 Apr 25;380(17):1618-1627. doi: 10.1056/NEJMoa1900486. Epub 2019 Mar 17.
• Colombo PC, Mehra MR, Goldstein DJ, Estep JD, Salerno C, Jorde UP, Cowger JA, Cleveland JC Jr, Uriel N, Sayer G, Skipper ER, Downey FX, Ono M, Hooker R Jr, Anyanwu AC, Givertz MM, Mahr C, Topuria I, Somo SI, Crandall DL, Horstmanshof DA. Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study. Circulation. 2019 Jan 8;139(2):155-168. doi: 10.1161/CIRCULATIONAHA.118.037231.
• Mehra MR, Salerno C, Naka Y, Uriel N, Cleveland JC, Horstmanshof D, Goldstein DJ; MOMENTUM 3 Investigators. A tale of the twist in the outflow graft: An analysis from the MOMENTUM 3 trial. J Heart Lung Transplant. 2018 Nov;37(11):1281-1284. doi: 10.1016/j.healun.2018.08.011. Epub 2018 Aug 24. No abstract available.
• Mehra MR, Salerno C, Cleveland JC, Pinney S, Yuzefpolskaya M, Milano CA, Itoh A, Goldstein DJ, Uriel N, Gulati S, Pagani FD, John R, Adamson R, Bogaev R, Thohan V, Chuang J, Sood P, Goates S, Silvestry SC. Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study. Circulation. 2018 Oct 30;138(18):1923-1934. doi: 10.1161/CIRCULATIONAHA.118.035722.
• Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11.
• Goldstein DJ, Mehra MR, Naka Y, Salerno C, Uriel N, Dean D, Itoh A, Pagani FD, Skipper ER, Bhat G, Raval N, Bruckner BA, Estep JD, Cogswell R, Milano C, Fendelander L, O'Connell JB, Cleveland J; MOMENTUM 3 Investigators. Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial. J Heart Lung Transplant. 2018 Jan;37(1):7-14. doi: 10.1016/j.healun.2017.11.001. Epub 2017 Nov 3.
• Cowger JA, Naka Y, Aaronson KD, Horstmanshof D, Gulati S, Rinde-Hoffman D, Pinney S, Adatya S, Farrar DJ, Jorde UP; MOMENTUM 3 Investigators. Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients. J Heart Lung Transplant. 2018 Jan;37(1):15-24. doi: 10.1016/j.healun.2017.10.019. Epub 2017 Oct 24.
• Uriel N, Colombo PC, Cleveland JC, Long JW, Salerno C, Goldstein DJ, Patel CB, Ewald GA, Tatooles AJ, Silvestry SC, John R, Caldeira C, Jeevanandam V, Boyle AJ, Sundareswaran KS, Sood P, Mehra MR. Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure. Circulation. 2017 May 23;135(21):2003-2012. doi: 10.1161/CIRCULATIONAHA.117.028303. Epub 2017 Apr 6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 21, 2014): 1028
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 26, 2019
• Actual Primary Completion Date: September 28, 2018 (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 heart failure (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 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 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 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:

    1. An INR ≥ 2.0 not due to anticoagulation therapy
    2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
    3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
    4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
    5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
    6. Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
    7. 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

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: NCT02224755
• Other Study ID Numbers: TC03062014
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Thoratec Corporation
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Thoratec Corporation
• Collaborators: Thoratec Corporation

Investigators

• Study Director: Daniel Crandall, PhD; Abbott

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