MOMENTUM 3 IDE Clinical Study Protocol (HM3™)

Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Advanced Refractory Left Ventricular Heart Failure
• Intervention / Treatment: Device: HeartMate 3 LVAS; Device: HeartMate II LVAS

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
• Enrollment (Actual): 1028
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.	Device: HeartMate II LVAS; Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Powered Secondary End Point: Pump Replacement at Two Years	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.	As they occur up to 24 months or to Outcome, whichever occurs first
EuroQoL 5D-5L (EQ-5D-5L) Total Score	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.	Baseline to 24 months
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 to 24 months
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 to 24 months
Six Minute Walk Test	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 to 24 months
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 to 24 months
Rehospitalizations	Rate of all cause rehospitalization	From initial discharge to two years post-implant
Adverse Event Rates	Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol	Two years post-implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Thoratec Corporation
• Investigators: Study Director: Daniel Crandall, PhD, Abbott

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2014
• Primary Completion (Actual): September 28, 2018
• Study Completion (Actual): March 26, 2019

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiovascular Disease; Cardiomyopathy; Heart Disease; Thoratec Corporation; Ventricular Dysfunction; Left Ventricular Assist Device; Heart-assist devices
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: TC03062014