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MOMENTUM 3 IDE Clinical Study Protocol (HM3™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02224755
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Refractory Left Ventricular Heart Failure
Interventions Device: HeartMate 3 LVAS
Device: HeartMate II LVAS
Enrollment 1028
Recruitment Details Subjects were recruited at 69 study sites in the United States from 2014 to 2016.
Pre-assignment Details  
Arm/Group Title HeartMate II (Intent-to-Treat) HeartMate 3 (Intent-to-Treat)
Hide Arm/Group Description Patients randomized to HeartMate II LVAS (control device) Patients randomized to HeartMate 3 LVAS
Period Title: Randomization to Device Implant
Started 512 [1] 516 [2]
Completed 505 [3] 515 [4]
Not Completed 7 1
Reason Not Completed
Withdrawn prior to implant             7             1
[1]
Patients in the Full Study Cohort (n=1028) who were randomized to HeartMate II
[2]
Patients in the Full Study Cohort (n=1028) who were randomized to HeartMate 3
[3]
Patients who underwent HeartMate II LVAS implant
[4]
Patients who underwent HeartMate 3 LVAS implant
Period Title: Two Year Follow up Post-implant
Started 505 515
Completed 247 289
Not Completed 258 226
Reason Not Completed
Death             103             98
Heart transplant             137             119
Device explant or permanent deactivation             3             3
Withdrawn post-implant             15             6
Arm/Group Title HeartMate II (Intent-to-Treat) HeartMate 3 (Intent-to-Treat) Total
Hide Arm/Group Description Patients randomized to HeartMate II LVAS (control device) Patients randomized to HeartMate 3 LVAS Total of all reporting groups
Overall Number of Baseline Participants 512 516 1028
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 512 participants 516 participants 1028 participants
60  (12) 59  (12) 60  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
Female
93
  18.2%
105
  20.3%
198
  19.3%
Male
419
  81.8%
411
  79.7%
830
  80.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race or ethnic group Number Analyzed 512 participants 516 participants 1028 participants
White
367
  71.7%
342
  66.3%
709
  69.0%
Black
120
  23.4%
145
  28.1%
265
  25.8%
Asian
3
   0.6%
8
   1.6%
11
   1.1%
Native Hawaiian or Pacific Islander
4
   0.8%
0
   0.0%
4
   0.4%
Other
18
   3.5%
21
   4.1%
39
   3.8%
Ischemic Cause of Heart Failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
240
  46.9%
216
  41.9%
456
  44.4%
History of Atrial Fibrillation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
238
  46.5%
215
  41.7%
453
  44.1%
History of Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
56
  10.9%
50
   9.7%
106
  10.3%
Intended Goal of Support  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
Bridge to transplantation
121
  23.6%
113
  21.9%
234
  22.8%
Bridge to candidacy for transplantation
81
  15.8%
86
  16.7%
167
  16.2%
Destination therapy
310
  60.5%
317
  61.4%
627
  61.0%
Inotropes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
423
  82.6%
445
  86.2%
868
  84.4%
Implantable cardioverter-defibrillator  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
382
  74.6%
352
  68.2%
734
  71.4%
Intra-aortic balloon pump  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
79
  15.4%
64
  12.4%
143
  13.9%
INTERMACS profile   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 516 participants 1028 participants
1
18
   3.5%
11
   2.1%
29
   2.8%
2
146
  28.5%
156
  30.2%
302
  29.4%
3
251
  49.0%
272
  52.7%
523
  50.9%
4
82
  16.0%
67
  13.0%
149
  14.5%
5-7 or not provided
15
   2.9%
10
   1.9%
25
   2.4%
[1]
Measure Description: INTERMACS profiles describe the clinical profile of advanced heart failure patients who may be candidates for mechanical circulatory support. There are 7 profiles ranging from Profile 1 (most sick) to Profile 7 (least sick). Profile 1 indicates critical cardiogenic shock. Profile 2 indicates progressive decline. Profile 3 indicates stable but inotrope dependent. Profile 4 indicates resting symptoms. Profile 5 indicates exertion intolerant. Profile 6 indicates exertion limited. Profile 7 indicates advanced NYHA Class 3 (clinically stable with a reasonable level of comfortable activity).
1.Primary Outcome
Title Short Term Primary End Point
Hide Description Survival at 6 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device
Time Frame The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
First 294 randomized Subjects
Arm/Group Title HeartMate II (Intent-to-Treat) HeartMate 3 (Intent-to-Treat)
Hide Arm/Group Description:
Patients randomized to HeartMate II LVAS (control device)
Patients randomized to HeartMate 3 LVAS
Overall Number of Participants Analyzed 142 152
Measure Type: Count of Participants
Unit of Measure: Participants
109
  76.8%
131
  86.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HeartMate II (Intent-to-Treat), HeartMate 3 (Intent-to-Treat)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Farrington-Manning risk difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.4
Confidence Interval (1-Sided) 95%
-2.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Long Term Primary End Point
Hide Description Survival at 2 years free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device
Time Frame The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
First 366 randomized Subjects
Arm/Group Title HeartMate II (Intent-to-Treat) HeartMate 3 (Intent-to-Treat)
Hide Arm/Group Description:
Patients randomized to HeartMate II LVAS (control device)
Patients randomized to HeartMate 3 LVAS
Overall Number of Participants Analyzed 176 190
Measure Type: Count of Participants
Unit of Measure: Participants
106
  60.2%
151
  79.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HeartMate II (Intent-to-Treat), HeartMate 3 (Intent-to-Treat)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Farrington-Manning risk difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 19.2
Confidence Interval (1-Sided) 95%
9.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Powered Secondary End Point: Pump Replacement at Two Years
Hide Description 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.
Time Frame As they occur up to 24 months or to Outcome, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who underwent implant with the assigned device
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Overall Number of Participants Analyzed 505 515
Measure Type: Count of Participants
Unit of Measure: Participants
57
  11.3%
12
   2.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HeartMate II (As-Treated), HeartMate 3 (As-Treated)
Comments Based on data in the Sponsor’s device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher’s exact test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
.11 to .38
Estimation Comments [Not Specified]
4.Secondary Outcome
Title EuroQoL 5D-5L (EQ-5D-5L) Total Score
Hide Description 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.
Time Frame Baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Overall Number of Participants Analyzed 505 515
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 475 participants 486 participants
11.2  (4.4) 11.1  (4.3)
6 months Number Analyzed 385 participants 418 participants
8.5  (3.2) 8.5  (3.3)
24 months Number Analyzed 227 participants 275 participants
9.2  (3.8) 8.8  (3.6)
5.Secondary Outcome
Title EuroQol-5D-5L Visual Analogue Scale
Hide Description 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.
Time Frame Baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Overall Number of Participants Analyzed 505 515
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baselline Number Analyzed 475 participants 486 participants
48  (25) 50  (24)
6 months Number Analyzed 386 participants 420 participants
74  (19) 76  (18)
24 months Number Analyzed 227 participants 276 participants
75  (19) 76  (19)
6.Secondary Outcome
Title Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Hide Description 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.
Time Frame Baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Overall Number of Participants Analyzed 505 515
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 482 participants 493 participants
40  (23) 39  (20)
6 months Number Analyzed 388 participants 421 participants
70  (21) 70  (20)
24 months Number Analyzed 227 participants 277 participants
68  (23) 69  (22)
7.Secondary Outcome
Title Six Minute Walk Test
Hide Description 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.
Time Frame Baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment. Patients unable to walk due to heart failure symptoms were assigned a distance of zero.
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Overall Number of Participants Analyzed 505 515
Mean (Standard Deviation)
Unit of Measure: meters
Baseline Number Analyzed 452 participants 471 participants
129  (156) 136  (160)
6 months Number Analyzed 333 participants 365 participants
327  (136) 310  (142)
24 months Number Analyzed 174 participants 211 participants
361  (337) 323  (156)
8.Secondary Outcome
Title New York Heart Association (NYHA) Classification
Hide Description 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.
Time Frame Baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Overall Number of Participants Analyzed 505 515
Measure Type: Count of Participants
Unit of Measure: Participants
Class I or II at Baseline Number Analyzed 504 participants 514 participants
0
   0.0%
0
   0.0%
Class I or II at 6 Months Number Analyzed 392 participants 428 participants
310
  79.1%
340
  79.4%
Class I or II at 24 Months Number Analyzed 229 participants 275 participants
176
  76.9%
219
  79.6%
9.Secondary Outcome
Title Rehospitalizations
Hide Description Rate of all cause rehospitalization
Time Frame From initial discharge to two years post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population only includes Subjects who were discharged on LVAD support from the implant hospitalization
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device and were discharged on LVAD support
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device and were discharged on LVAD support
Overall Number of Participants Analyzed 471 485
Measure Type: Number
Unit of Measure: events per patient year
2.47 2.26
10.Secondary Outcome
Title Adverse Event Rates
Hide Description Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Time Frame Two years post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description:
Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device
Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Overall Number of Participants Analyzed 505 515
Measure Type: Number
Unit of Measure: events per patient year
Arterial Non-CNS Thromboembolism 0.02 0.01
Bleeding 0.95 0.61
Cardiac Arrhythmia 0.45 0.37
Hepatic Dysfunction 0.04 0.03
Hypertension 0.08 0.07
Major Infection 0.82 0.82
Myocardial Infarction 0.01 0.01
Stroke 0.18 0.08
Hemorrhagic Stroke 0.07 0.03
Ischemic Stroke 0.11 0.04
Debilitating Stroke 0.07 0.04
Other Neurological Event 0.08 0.09
Pericardial Fluid Collection 0.07 0.04
Psychiatric Episode 0.07 0.08
Renal Dysfunction 0.08 0.11
Respiratory Failure 0.17 0.19
Right Heart Failure 0.23 0.27
RVAD 0.03 0.03
Venous Thromboembolism 0.04 0.04
Wound Dehiscence 0.02 0.01
Suspected Device Thrombosis 0.12 0.01
Hemolysis 0.01 0.01
Time Frame Two years post-implant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Hide Arm/Group Description Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
All-Cause Mortality
HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Affected / at Risk (%) Affected / at Risk (%)
Total   103/505 (20.40%)   98/515 (19.03%) 
Hide Serious Adverse Events
HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Affected / at Risk (%) Affected / at Risk (%)
Total   466/505 (92.28%)   483/515 (93.79%) 
Blood and lymphatic system disorders     
Bleeding  1  271/505 (53.66%)  214/515 (41.55%) 
Hemolysis  1  8/505 (1.58%)  6/515 (1.17%) 
Cardiac disorders     
Cardiac Arrhythmia  1  174/505 (34.46%)  149/515 (28.93%) 
Myocardial Infarction  1  5/505 (0.99%)  6/515 (1.17%) 
Pericardial Fluid Collection  1  44/505 (8.71%)  25/515 (4.85%) 
Right Heart Failure  1  127/505 (25.15%)  151/515 (29.32%) 
General disorders     
Other  1  277/505 (54.85%)  340/515 (66.02%) 
Hepatobiliary disorders     
Hepatic Dysfunction  1  23/505 (4.55%)  20/515 (3.88%) 
Infections and infestations     
Major Infection  1  251/505 (49.70%)  274/515 (53.20%) 
Nervous system disorders     
Stroke  1  98/505 (19.41%)  51/515 (9.90%) 
Other Neurological Event  1  47/505 (9.31%)  59/515 (11.46%) 
Product Issues     
Suspected Device Thrombosis  1  70/505 (13.86%)  7/515 (1.36%) 
Psychiatric disorders     
Psychiatric Episode  1  24/505 (4.75%)  31/515 (6.02%) 
Renal and urinary disorders     
Renal Dysfunction  1  52/505 (10.30%)  70/515 (13.59%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure  1  94/505 (18.61%)  110/515 (21.36%) 
Skin and subcutaneous tissue disorders     
Wound Dehiscence  1  8/505 (1.58%)  4/515 (0.78%) 
Vascular disorders     
Arterial Non-CNS Thromboembolism  1  10/505 (1.98%)  5/515 (0.97%) 
Hypertension  1  18/505 (3.56%)  23/515 (4.47%) 
Venous Thromboembolism  1  14/505 (2.77%)  20/515 (3.88%) 
1
Term from vocabulary, Study Protocol
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HeartMate II (As-Treated) HeartMate 3 (As-Treated)
Affected / at Risk (%) Affected / at Risk (%)
Total   235/505 (46.53%)   261/515 (50.68%) 
Blood and lymphatic system disorders     
Bleeding  1  26/505 (5.15%)  31/515 (6.02%) 
Cardiac disorders     
Cardiac Arrhythmia  1  46/505 (9.11%)  54/515 (10.49%) 
Right Heart Failure  1  19/505 (3.76%)  28/515 (5.44%) 
General disorders     
Other Adverse Event  1  113/505 (22.38%)  139/515 (26.99%) 
Infections and infestations     
Major Infection  1  79/505 (15.64%)  95/515 (18.45%) 
Psychiatric disorders     
Psychiatric Episode  1  21/505 (4.16%)  24/515 (4.66%) 
Vascular disorders     
Hypertension  1  29/505 (5.74%)  19/515 (3.69%) 
1
Term from vocabulary, Study Protocol
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MOMENTUM 3 has a study specific charter that governs the overall publication and presentation policy for all abstracts and manuscripts related to MOMENTUM 3 clinical data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joyce Chuang/Principal scientist
Organization: Abbott
Phone: 925-353-5817
EMail: joyce.chuang@abbott.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02224755    
Other Study ID Numbers: TC03062014
First Submitted: August 21, 2014
First Posted: August 25, 2014
Results First Submitted: October 2, 2019
Results First Posted: November 20, 2019
Last Update Posted: November 20, 2019