Trial Outcomes & Findings for MOMENTUM 3 IDE Clinical Study Protocol (NCT NCT02224755)

NCT ID: NCT02224755

Last Updated: 2022-06-27

Results Overview

Survival at 6 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1028 participants
• Primary outcome timeframe: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.
• Results posted on: 2022-06-27

Participant Flow

Subjects were recruited at 69 study sites in the United States from 2014 to 2016.

Participant milestones

Measure	HeartMate II (Intent-to-Treat) Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) Patients randomized to HeartMate 3 LVAS
Randomization to Device Implant STARTED	512	516
Randomization to Device Implant COMPLETED	505	515
Randomization to Device Implant NOT COMPLETED	7	1
Two Year Follow up Post-implant STARTED	505	515
Two Year Follow up Post-implant COMPLETED	247	289
Two Year Follow up Post-implant NOT COMPLETED	258	226

Reasons for withdrawal

Measure	HeartMate II (Intent-to-Treat) Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) Patients randomized to HeartMate 3 LVAS
Randomization to Device Implant Withdrawn prior to implant	7	1
Two Year Follow up Post-implant Death	103	98
Two Year Follow up Post-implant Heart transplant	137	119
Two Year Follow up Post-implant Device explant or permanent deactivation	3	3
Two Year Follow up Post-implant Withdrawn post-implant	15	6

Baseline Characteristics

MOMENTUM 3 IDE Clinical Study Protocol

Baseline characteristics by cohort

Measure	HeartMate II (Intent-to-Treat) n=512 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=516 Participants Patients randomized to HeartMate 3 LVAS	Total n=1028 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 12 • n=5 Participants	59 years STANDARD_DEVIATION 12 • n=7 Participants	60 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	105 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	419 Participants n=5 Participants	411 Participants n=7 Participants	830 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · White	367 Participants n=5 Participants	342 Participants n=7 Participants	709 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Black	120 Participants n=5 Participants	145 Participants n=7 Participants	265 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Asian	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Native Hawaiian or Pacific Islander	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Other	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Ischemic Cause of Heart Failure	240 Participants n=5 Participants	216 Participants n=7 Participants	456 Participants n=5 Participants
History of Atrial Fibrillation	238 Participants n=5 Participants	215 Participants n=7 Participants	453 Participants n=5 Participants
History of Stroke	56 Participants n=5 Participants	50 Participants n=7 Participants	106 Participants n=5 Participants
Intended Goal of Support Bridge to transplantation	121 Participants n=5 Participants	113 Participants n=7 Participants	234 Participants n=5 Participants
Intended Goal of Support Bridge to candidacy for transplantation	81 Participants n=5 Participants	86 Participants n=7 Participants	167 Participants n=5 Participants
Intended Goal of Support Destination therapy	310 Participants n=5 Participants	317 Participants n=7 Participants	627 Participants n=5 Participants
Inotropes	423 Participants n=5 Participants	445 Participants n=7 Participants	868 Participants n=5 Participants
Implantable cardioverter-defibrillator	382 Participants n=5 Participants	352 Participants n=7 Participants	734 Participants n=5 Participants
Intra-aortic balloon pump	79 Participants n=5 Participants	64 Participants n=7 Participants	143 Participants n=5 Participants
INTERMACS profile 1	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
INTERMACS profile 2	146 Participants n=5 Participants	156 Participants n=7 Participants	302 Participants n=5 Participants
INTERMACS profile 3	251 Participants n=5 Participants	272 Participants n=7 Participants	523 Participants n=5 Participants
INTERMACS profile 4	82 Participants n=5 Participants	67 Participants n=7 Participants	149 Participants n=5 Participants
INTERMACS profile 5-7 or not provided	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.

Population: First 294 randomized Subjects

Survival at 6 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=142 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=152 Participants Patients randomized to HeartMate 3 LVAS
Short Term Primary End Point	109 Participants	131 Participants

PRIMARY outcome

Timeframe: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Population: First 366 randomized Subjects

Survival at 2 years free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=176 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=190 Participants Patients randomized to HeartMate 3 LVAS
Long Term Primary End Point	106 Participants	151 Participants

SECONDARY outcome

Timeframe: As they occur up to 24 months or to Outcome, whichever occurs first

Population: All subjects who underwent implant with the assigned device

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.

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=505 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=515 Participants Patients randomized to HeartMate 3 LVAS
Powered Secondary End Point: Pump Replacement at Two Years	57 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline to 24 months

Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment

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.

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=505 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=515 Participants Patients randomized to HeartMate 3 LVAS
EuroQoL 5D-5L (EQ-5D-5L) Total Score Baseline	11.2 score on a scale Standard Deviation 4.4	11.1 score on a scale Standard Deviation 4.3
EuroQoL 5D-5L (EQ-5D-5L) Total Score 6 months	8.5 score on a scale Standard Deviation 3.2	8.5 score on a scale Standard Deviation 3.3
EuroQoL 5D-5L (EQ-5D-5L) Total Score 24 months	9.2 score on a scale Standard Deviation 3.8	8.8 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline to 24 months

Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment

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.

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=505 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=515 Participants Patients randomized to HeartMate 3 LVAS
EuroQol-5D-5L Visual Analogue Scale Baselline	48 score on a scale Standard Deviation 25	50 score on a scale Standard Deviation 24
EuroQol-5D-5L Visual Analogue Scale 6 months	74 score on a scale Standard Deviation 19	76 score on a scale Standard Deviation 18
EuroQol-5D-5L Visual Analogue Scale 24 months	75 score on a scale Standard Deviation 19	76 score on a scale Standard Deviation 19

SECONDARY outcome

Timeframe: Baseline to 24 months

Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment

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.

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=505 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=515 Participants Patients randomized to HeartMate 3 LVAS
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score Baseline	40 score on a scale Standard Deviation 23	39 score on a scale Standard Deviation 20
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score 6 months	70 score on a scale Standard Deviation 21	70 score on a scale Standard Deviation 20
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score 24 months	68 score on a scale Standard Deviation 23	69 score on a scale Standard Deviation 22

SECONDARY outcome

Timeframe: Baseline to 24 months

Population: 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.

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.

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=505 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=515 Participants Patients randomized to HeartMate 3 LVAS
Six Minute Walk Test 24 months	361 meters Standard Deviation 337	323 meters Standard Deviation 156
Six Minute Walk Test Baseline	129 meters Standard Deviation 156	136 meters Standard Deviation 160
Six Minute Walk Test 6 months	327 meters Standard Deviation 136	310 meters Standard Deviation 142

SECONDARY outcome

Timeframe: Baseline to 24 months

Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment

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.

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=505 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=515 Participants Patients randomized to HeartMate 3 LVAS
New York Heart Association (NYHA) Classification Class I or II at Baseline	0 Participants	0 Participants
New York Heart Association (NYHA) Classification Class I or II at 6 Months	310 Participants	340 Participants
New York Heart Association (NYHA) Classification Class I or II at 24 Months	176 Participants	219 Participants

SECONDARY outcome

Timeframe: From initial discharge to two years post-implant

Population: Analysis population only includes Subjects who were discharged on LVAD support from the implant hospitalization

Rate of all cause rehospitalization

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=471 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=485 Participants Patients randomized to HeartMate 3 LVAS
Rehospitalizations	2.47 events per patient year	2.26 events per patient year

SECONDARY outcome

Timeframe: Two years post-implant

Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol

Outcome measures

Measure	HeartMate II (Intent-to-Treat) n=505 Participants Patients randomized to HeartMate II LVAS (control device)	HeartMate 3 (Intent-to-Treat) n=515 Participants Patients randomized to HeartMate 3 LVAS
Adverse Event Rates Venous Thromboembolism	0.04 events per patient year	0.04 events per patient year
Adverse Event Rates Wound Dehiscence	0.02 events per patient year	0.01 events per patient year
Adverse Event Rates Arterial Non-CNS Thromboembolism	0.02 events per patient year	0.01 events per patient year
Adverse Event Rates Bleeding	0.95 events per patient year	0.61 events per patient year
Adverse Event Rates Cardiac Arrhythmia	0.45 events per patient year	0.37 events per patient year
Adverse Event Rates Hepatic Dysfunction	0.04 events per patient year	0.03 events per patient year
Adverse Event Rates Hypertension	0.08 events per patient year	0.07 events per patient year
Adverse Event Rates Major Infection	0.82 events per patient year	0.82 events per patient year
Adverse Event Rates Myocardial Infarction	0.01 events per patient year	0.01 events per patient year
Adverse Event Rates Stroke	0.18 events per patient year	0.08 events per patient year
Adverse Event Rates Hemorrhagic Stroke	0.07 events per patient year	0.03 events per patient year
Adverse Event Rates Ischemic Stroke	0.11 events per patient year	0.04 events per patient year
Adverse Event Rates Debilitating Stroke	0.07 events per patient year	0.04 events per patient year
Adverse Event Rates Other Neurological Event	0.08 events per patient year	0.09 events per patient year
Adverse Event Rates Pericardial Fluid Collection	0.07 events per patient year	0.04 events per patient year
Adverse Event Rates Psychiatric Episode	0.07 events per patient year	0.08 events per patient year
Adverse Event Rates Renal Dysfunction	0.08 events per patient year	0.11 events per patient year
Adverse Event Rates Respiratory Failure	0.17 events per patient year	0.19 events per patient year
Adverse Event Rates Right Heart Failure	0.23 events per patient year	0.27 events per patient year
Adverse Event Rates RVAD	0.03 events per patient year	0.03 events per patient year
Adverse Event Rates Suspected Device Thrombosis	0.12 events per patient year	0.01 events per patient year
Adverse Event Rates Hemolysis	0.01 events per patient year	0.01 events per patient year

Adverse Events

HeartMate II (As-Treated)

Serious events: 466 serious events

Other events: 235 other events

Deaths: 103 deaths

HeartMate 3 (As-Treated)

Serious events: 483 serious events

Other events: 261 other events

Deaths: 98 deaths

Serious adverse events

Measure	HeartMate II (As-Treated) n=505 participants at risk Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device	HeartMate 3 (As-Treated) n=515 participants at risk Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Vascular disorders Arterial Non-CNS Thromboembolism	2.0% 10/505 • Two years post-implant	0.97% 5/515 • Two years post-implant
Blood and lymphatic system disorders Bleeding	53.7% 271/505 • Two years post-implant	41.6% 214/515 • Two years post-implant
Cardiac disorders Cardiac Arrhythmia	34.5% 174/505 • Two years post-implant	28.9% 149/515 • Two years post-implant
Hepatobiliary disorders Hepatic Dysfunction	4.6% 23/505 • Two years post-implant	3.9% 20/515 • Two years post-implant
Vascular disorders Hypertension	3.6% 18/505 • Two years post-implant	4.5% 23/515 • Two years post-implant
Infections and infestations Major Infection	49.7% 251/505 • Two years post-implant	53.2% 274/515 • Two years post-implant
Cardiac disorders Myocardial Infarction	0.99% 5/505 • Two years post-implant	1.2% 6/515 • Two years post-implant
Nervous system disorders Stroke	19.4% 98/505 • Two years post-implant	9.9% 51/515 • Two years post-implant
Nervous system disorders Other Neurological Event	9.3% 47/505 • Two years post-implant	11.5% 59/515 • Two years post-implant
Cardiac disorders Pericardial Fluid Collection	8.7% 44/505 • Two years post-implant	4.9% 25/515 • Two years post-implant
Psychiatric disorders Psychiatric Episode	4.8% 24/505 • Two years post-implant	6.0% 31/515 • Two years post-implant
Renal and urinary disorders Renal Dysfunction	10.3% 52/505 • Two years post-implant	13.6% 70/515 • Two years post-implant
Respiratory, thoracic and mediastinal disorders Respiratory Failure	18.6% 94/505 • Two years post-implant	21.4% 110/515 • Two years post-implant
Cardiac disorders Right Heart Failure	25.1% 127/505 • Two years post-implant	29.3% 151/515 • Two years post-implant
Vascular disorders Venous Thromboembolism	2.8% 14/505 • Two years post-implant	3.9% 20/515 • Two years post-implant
Skin and subcutaneous tissue disorders Wound Dehiscence	1.6% 8/505 • Two years post-implant	0.78% 4/515 • Two years post-implant
Product Issues Suspected Device Thrombosis	13.9% 70/505 • Two years post-implant	1.4% 7/515 • Two years post-implant
Blood and lymphatic system disorders Hemolysis	1.6% 8/505 • Two years post-implant	1.2% 6/515 • Two years post-implant
General disorders Other	54.9% 277/505 • Two years post-implant	66.0% 340/515 • Two years post-implant

Other adverse events

Measure	HeartMate II (As-Treated) n=505 participants at risk Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device	HeartMate 3 (As-Treated) n=515 participants at risk Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device
Blood and lymphatic system disorders Bleeding	5.1% 26/505 • Two years post-implant	6.0% 31/515 • Two years post-implant
Cardiac disorders Cardiac Arrhythmia	9.1% 46/505 • Two years post-implant	10.5% 54/515 • Two years post-implant
Vascular disorders Hypertension	5.7% 29/505 • Two years post-implant	3.7% 19/515 • Two years post-implant
Infections and infestations Major Infection	15.6% 79/505 • Two years post-implant	18.4% 95/515 • Two years post-implant
Psychiatric disorders Psychiatric Episode	4.2% 21/505 • Two years post-implant	4.7% 24/515 • Two years post-implant
Cardiac disorders Right Heart Failure	3.8% 19/505 • Two years post-implant	5.4% 28/515 • Two years post-implant
General disorders Other Adverse Event	22.4% 113/505 • Two years post-implant	27.0% 139/515 • Two years post-implant

Additional Information

Joyce Chuang/Principal scientist

Abbott

Phone: 925-353-5817

Email: joyce.chuang@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER