MOMENTUM 3 Continued Access Protocol (MOMENTUM 3 CAP)

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

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Refractory Left Ventricular Heart Failure
• Intervention: Device: HeartMate 3 LVAS
• Enrollment: 1685

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	HeartMate 3 LVAS (HM3 LVAS)
Arm/Group Description	The study will be a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS. HeartMate 3 LVAS: Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
Period Title: Overall Study
Started	1685
Completed	1685
Not Completed	0

Baseline Characteristics

Arm/Group Title		HeartMate 3 LVAS (HM3 LVAS)
Arm/Group Description		The study will be a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS. HeartMate 3 LVAS: Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
Overall Number of Baseline Participants		1685
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1685 participants
		59.9 (12.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1685 participants
	Female	343 20.4%
	Male	1342 79.6%
Race (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1685 participants
	American Indian or Alaska Native	0 0.0%
	Asian	19 1.1%
	Native Hawaiian or Other Pacific Islander	10 0.6%
	Black or African American	466 27.7%
	White	1135 67.4%
	More than one race	53 3.1%
	Unknown or Not Reported	2 0.1%
		[1] Measure Description: Participants in the "more than one race" category include those who also specified a race other than Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or White race.
INTERMACS Profile [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1685 participants
	1	69 4.1%
	2	517 30.7%
	3	843 50.0%
	4	216 12.8%
	5	24 1.4%
	6 or 7	1 0.1%
	Not provided	15 0.9%
		[1] Measure Description: Lower profiles are considered worse. Profile 1 describes patients in critical cardiogenic shock. Profile 2 describes patients with inotrope dependence who show signs of continuing deterioration. Profile 3 describes stable, inotrope dependent patients. Profile 4 describes patients at home on oral therapy with symptoms of congestion at rest. Profile 5 describes exertion intolerant patients who are comfortable at rest. Profile 6 describes exertion limited patients who are comfortable at rest. Profile 7 describes clinically stable patients with reasonable levels of comfortable activity.
Intended Goal of Support [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1685 participants
	Bridge to Transplant	173 10.3%
	Bridge to Candidacy	233 13.8%
	Destination Therapy	1274 75.6%
	Bridge to Recovery	4 0.2%
	Rescue Therapy	1 0.1%
		[1] Measure Description: Bridge to recovery: Use of a durable device to allow recovery from chronic cardiac failure. Rescue therapy: Use of a durable device to support resolution from an acute event without major previous cardiac dysfunction. Bridge to transplant: Patient listed for transplant or listed within 24 hours before device implantation. Bridge to candidacy: Patient may be eligible for transplant. Destination therapy: patient definitely not eligible for transplant.

Outcome Measures

1. Primary Outcome

Title	Event-Free Survival
Description	Survival at 24 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device
Time Frame	Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HeartMate 3 LVAS (HM3 LVAS)
Arm/Group Description:	Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed	1685
Measure Type: Count of Participants; Unit of Measure: Participants
	1320 78.3%

2. Secondary Outcome

Title	Pump Replacement
Description	Frequency of HeartMate 3 pump replacement at 24 months.
Time Frame	As they occur up to 24 months or to outcome, whichever occurs first

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HeartMate 3 LVAS (HM3 LVAS)
Arm/Group Description:	Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed	1685
Measure Type: Count of Participants; Unit of Measure: Participants
	20 1.2%

3. Secondary Outcome

Title	Six Minute Walk Test (6MWT)
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, 6 months and 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 3 LVAS (HM3 LVAS)
Arm/Group Description:		Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed		1685
Mean (Standard Deviation); Unit of Measure: meters
Baseline	Number Analyzed	1487 participants
		101.3 (160.7)
6 months	Number Analyzed	1140 participants
		317.2 (163.3)
24 months	Number Analyzed	664 participants
		305.1 (172.5)

4. 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, 6 months and 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 3 LVAS (HM3 LVAS)
Arm/Group Description:		Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed		1685
Measure Type: Count of Participants; Unit of Measure: Participants
NYHA Class I or II at Baseline	Number Analyzed	1673 participants
		0 0.0%
Class I or II at 6 Months	Number Analyzed	1344 participants
		1046 77.8%
Class I or II at 24 Months	Number Analyzed	949 participants
		686 72.3%

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, 6 months and 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 3 LVAS (HM3 LVAS)
Arm/Group Description:		Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed		1685
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	1602 participants
		48.3 (25.1)
6 months	Number Analyzed	1326 participants
		73.9 (18.2)
24 months	Number Analyzed	922 participants
		72.4 (20.1)

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, 6 months and 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 3 LVAS (HM3 LVAS)
Arm/Group Description:		Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed		1685
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline	Number Analyzed	1610 participants
		40.0 (21.6)
6 months	Number Analyzed	1325 participants
		69.5 (20.0)
24 months	Number Analyzed	923 participants
		67.3 (21.8)

7. Secondary Outcome

Title	Rehospitalizations
Description	Rate of all cause rehospitalization
Time Frame	From initial discharge to 2 years post-implant

Outcome Measure Data

Analysis Population Description

Subjects who were discharged on LVAD support from the implant hospitalization

Arm/Group Title	HeartMate 3 LVAS (HM3 LVAS)
Arm/Group Description:	Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed	1571
Measure Type: Number; Unit of Measure: events per patient year
	2.03

8. Secondary Outcome

Title	Adverse Event Rates
Description	Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Time Frame	2 years post-implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HeartMate 3 LVAS (HM3 LVAS)
Arm/Group Description:	Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
Overall Number of Participants Analyzed	1685
Measure Type: Number; Unit of Measure: events per patient year
Arterial Non-CNS Thromboembolism	0.01
Bleeding	0.71
Cardiac Arrhythmia	0.30
Hepatic Dysfunction	0.04
Hypertension	0.04
Major Infection	0.73
Myocardial Infarction	0.01
Stroke	0.07
Other Neurological Event	0.09
Pericardial Fluid Collection	0.04
Psychiatric Episode	0.07
Renal Dysfunction	0.11
Respiratory Failure	0.16
Right Heart Failure	0.27
Venous Thromboembolism	0.03
Wound Dehiscence	0.00
Suspected Device Thrombosis	0.01
Hemolysis	0.00

Adverse Events

Time Frame	2 years post-implant
Adverse Event Reporting Description	Serious adverse events are defined as those adverse events causing death, or congenital abnormality or birth defect, or a life-threatening illness or injury that results in permanent disability, requires hospitalization, or prolongs a hospitalization, and/or requires intervention to prevent permanent injury or damage.
Arm/Group Title	HeartMate 3 LVAS (HM3 LVAS)
Arm/Group Description	Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
All-Cause Mortality
	HeartMate 3 LVAS (HM3 LVAS)
	Affected / at Risk (%)
Total	293/1685 (17.39%)
Serious Adverse Events
	HeartMate 3 LVAS (HM3 LVAS)
	Affected / at Risk (%)
Total	1536/1685 (91.16%)
Blood and lymphatic system disorders
Protocol defined bleeding † 1 [1]	802/1685 (47.60%)
Protocol defined hemolysis † 1 [1]	6/1685 (0.36%)
Cardiac disorders
Protocol defined cardiac arrhythmia † 1 [1]	473/1685 (28.07%)
Protocol defined myocardial infarction † 1 [1]	15/1685 (0.89%)
Protocol defined pericardial fluid collection † 1 [1]	96/1685 (5.70%)
Protocol defined right heart failure † 1 [1]	541/1685 (32.11%)
General disorders
Protocol defined other adverse event † 1 [1]	1084/1685 (64.33%)
Hepatobiliary disorders
Protocol defined hepatic dysfunction † 1 [1]	58/1685 (3.44%)
Infections and infestations
Protocol defined major infection † 1 [1]	862/1685 (51.16%)
Nervous system disorders
Protocol defined stroke † 1 [1]	153/1685 (9.08%)
Protocol defined other neurological event † 1 [1]	202/1685 (11.99%)
Product Issues
Protocol defined suspected device thrombosis † 1 [1]	18/1685 (1.07%)
Psychiatric disorders
Protocol defined psychiatric episode † 1 [1]	73/1685 (4.33%)
Renal and urinary disorders
Protocol defined renal dysfunction † 1 [1]	231/1685 (13.71%)
Respiratory, thoracic and mediastinal disorders
Protocol defined respiratory failure † 1 [1]	325/1685 (19.29%)
Skin and subcutaneous tissue disorders
Protocol defined wound dehiscence † 1 [1]	10/1685 (0.59%)
Vascular disorders
Protocol defined arterial non-CNS thromboembolism † 1 [1]	21/1685 (1.25%)
Protocol defined hypertension † 1 [1]	45/1685 (2.67%)
Protocol defined venous thromboembolism † 1 [1]	30/1685 (1.78%)
1 Term from vocabulary, Study Protocol; † Indicates events were collected by systematic assessment; [1] Events categorized based on detailed definition specified in the study protocol.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	HeartMate 3 LVAS (HM3 LVAS)
	Affected / at Risk (%)
Total	1050/1685 (62.31%)
Blood and lymphatic system disorders
Protocol defined bleeding † 1 [1]	107/1685 (6.35%)
Cardiac disorders
Protocol defined cardiac arrhythmia † 1 [1]	135/1685 (8.01%)
Protocol defined right heart failure † 1 [1]	107/1685 (6.35%)
General disorders
Protocol defined other adverse event † 1 [1]	617/1685 (36.62%)
Infections and infestations
Protocol defined major infection † 1 [1]	267/1685 (15.85%)
Psychiatric disorders
Protocol defined psychiatric episode † 1 [1]	94/1685 (5.58%)
1 Term from vocabulary, Study Protocol; † Indicates events were collected by systematic assessment; [1] Events categorized based on detailed definition specified in the study protocol.

Limitations and Caveats

This is a single arm 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 studies have 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
• Organization: Abbott
• Phone: 9253535817
• EMail: joyce.chuang@abbott.com

Publications of Results:

Mehra MR, Cleveland JC Jr, Uriel N, Cowger JA, Hall S, Horstmanshof D, Naka Y, Salerno CT, Chuang J, Williams C, Goldstein DJ; MOMENTUM 3 Investigators. Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants. Eur J Heart Fail. 2021 Aug;23(8):1392-1400. doi: 10.1002/ejhf.2211. Epub 2021 May 18.

Other Publications:

Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.

Uriel N, Adatya S, Mehra MR. Evolution in Mechanical Circulatory Support: Are We at the Precipice of a Disruptive Innovation? J Am Coll Cardiol. 2015 Dec 15;66(23):2590-2593. doi: 10.1016/j.jacc.2015.10.028. No abstract available.

Schmitto JD, Hanke JS, Rojas SV, Avsar M, Haverich A. First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III). J Heart Lung Transplant. 2015 Jun;34(6):858-60. doi: 10.1016/j.healun.2015.03.001. Epub 2015 Mar 7. No abstract available.

Netuka I, Kvasnicka T, Kvasnicka J, Hrachovinova I, Ivak P, Marecek F, Bilkova J, Malikova I, Jancova M, Maly J, Sood P, Sundareswaran KS, Connors JM, Mehra MR. Evaluation of von Willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure. J Heart Lung Transplant. 2016 Jul;35(7):860-7. doi: 10.1016/j.healun.2016.05.019. Epub 2016 May 31.

Bourque K, Cotter C, Dague C, Harjes D, Dur O, Duhamel J, Spink K, Walsh K, Burke E. Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular Assist System for Hemocompatibility. ASAIO J. 2016 Jul-Aug;62(4):375-83. doi: 10.1097/MAT.0000000000000388.

Hanke JS, Haverich A, Schmitto JD. Exchange of a HeartMate II left ventricular assist device with a HeartMate 3 pump. J Heart Lung Transplant. 2016 Jul;35(7):944-6. doi: 10.1016/j.healun.2016.03.013. Epub 2016 Mar 30. No abstract available.

Heatley G, Sood P, Goldstein D, Uriel N, Cleveland J, Middlebrook D, Mehra MR; MOMENTUM 3 Investigators. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant. 2016 Apr;35(4):528-36. doi: 10.1016/j.healun.2016.01.021. Epub 2016 Jan 30.

Schulz A, Stepanenko A, Krabatsch T. HeartMate 3 implantation via left lateral thoracotomy with outflow graft anastomosis to the descending aorta. J Heart Lung Transplant. 2016 May;35(5):690-2. doi: 10.1016/j.healun.2016.01.004. Epub 2016 Jan 15. No abstract available.

Stansfield WE, Rao V. HeartMate 3: Facing the challenge of past success. J Thorac Cardiovasc Surg. 2016 Sep;152(3):683-5. doi: 10.1016/j.jtcvs.2016.04.048. Epub 2016 Apr 22. No abstract available.

Takayama H. Did you like Terminator 3 better than Terminator 2? "Rise of machines" with HeartMate 3? J Thorac Cardiovasc Surg. 2016 Sep;152(3):686-7. doi: 10.1016/j.jtcvs.2016.05.044. Epub 2016 Jun 2. No abstract available.

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

Vidula H, Takeda K, Estep JD, Silvestry SC, Milano C, Cleveland JC Jr, Goldstein DJ, Uriel N, Kormos RL, Dirckx N, Mehra MR. Hospitalization Patterns and Impact of a Magnetically-Levitated Left Ventricular Assist Device in the MOMENTUM 3 Trial. JACC Heart Fail. 2022 Jul;10(7):470-481. doi: 10.1016/j.jchf.2022.03.007. Epub 2022 Jun 8.

Sheikh FH, Ravichandran AK, Goldstein DJ, Agarwal R, Ransom J, Bansal A, Kim G, Cleveland JC, Uriel N, Sheridan BC, Chomsky D, Patel SR, Dirckx N, Franke A, Mehra MR. Impact of Race on Clinical Outcomes After Implantation With a Fully Magnetically Levitated Left Ventricular Assist Device: An Analysis From the MOMENTUM 3 Trial. Circ Heart Fail. 2021 Oct;14(10):e008360. doi: 10.1161/CIRCHEARTFAILURE.120.008360. Epub 2021 Sep 16.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02892955
• Other Study ID Numbers: MOMENTUM 3 CAP
• First Submitted: August 24, 2016
• First Posted: September 8, 2016
• Results First Submitted: January 4, 2022
• Results First Posted: March 3, 2022
• Last Update Posted: June 27, 2022