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

• 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

Participant Flow

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)
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Withdrawn prior to implant	7	1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Withdrawn post-implant	15	6

Baseline Characteristics

Arm/Group Title		HeartMate II (Intent-to-Treat)	HeartMate 3 (Intent-to-Treat)	Total
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
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).

Outcome Measures

1. Primary Outcome

Title	Short Term Primary End Point
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.

Outcome Measure Data

Analysis Population Description

First 294 randomized Subjects

Arm/Group Title	HeartMate II (Intent-to-Treat)	HeartMate 3 (Intent-to-Treat)
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%

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
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.

Outcome Measure Data

Analysis Population Description

First 366 randomized Subjects

Arm/Group Title	HeartMate II (Intent-to-Treat)	HeartMate 3 (Intent-to-Treat)
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%

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
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

Outcome Measure Data

Analysis Population Description

All subjects who underwent implant with the assigned device

Arm/Group Title	HeartMate II (As-Treated)	HeartMate 3 (As-Treated)
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%

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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
Description	Rate of all cause rehospitalization
Time Frame	From initial discharge to two years post-implant

Outcome Measure Data

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)
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
Description	Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Time Frame	Two years post-implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HeartMate II (As-Treated)	HeartMate 3 (As-Treated)
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

Adverse Events

Time Frame	Two years post-implant
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	HeartMate II (As-Treated)	HeartMate 3 (As-Treated)
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%)
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
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

Limitations and Caveats

This was a non-blinded study

More Information

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

• Name/Title: Joyce Chuang/Principal scientist
• Organization: Abbott
• Phone: 925-353-5817
• EMail: joyce.chuang@abbott.com

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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: June 27, 2022