Trial Outcomes & Findings for MOMENTUM 3 Continued Access Protocol (NCT NCT02892955)
NCT ID: NCT02892955
Last Updated: 2022-06-27
Results Overview
Survival at 24 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
1685 participants
Primary outcome timeframe
Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Results posted on
2022-06-27
Participant Flow
Participant milestones
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
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.
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|---|---|
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Overall Study
STARTED
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1685
|
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Overall Study
COMPLETED
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1685
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MOMENTUM 3 Continued Access Protocol
Baseline characteristics by cohort
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
n=1685 Participants
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.
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|---|---|
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Age, Continuous
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59.9 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
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Sex: Female, Male
Female
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343 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
1342 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
466 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1135 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
53 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
INTERMACS Profile
1
|
69 Participants
n=99 Participants
|
|
INTERMACS Profile
2
|
517 Participants
n=99 Participants
|
|
INTERMACS Profile
3
|
843 Participants
n=99 Participants
|
|
INTERMACS Profile
4
|
216 Participants
n=99 Participants
|
|
INTERMACS Profile
5
|
24 Participants
n=99 Participants
|
|
INTERMACS Profile
6 or 7
|
1 Participants
n=99 Participants
|
|
INTERMACS Profile
Not provided
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15 Participants
n=99 Participants
|
|
Intended Goal of Support
Bridge to Transplant
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173 Participants
n=99 Participants
|
|
Intended Goal of Support
Bridge to Candidacy
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233 Participants
n=99 Participants
|
|
Intended Goal of Support
Destination Therapy
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1274 Participants
n=99 Participants
|
|
Intended Goal of Support
Bridge to Recovery
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4 Participants
n=99 Participants
|
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Intended Goal of Support
Rescue Therapy
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1 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.Survival at 24 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Outcome measures
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
n=1685 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Event-Free Survival
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1320 Participants
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SECONDARY outcome
Timeframe: As they occur up to 24 months or to outcome, whichever occurs firstFrequency of HeartMate 3 pump replacement at 24 months.
Outcome measures
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
n=1685 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Pump Replacement
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20 Participants
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SECONDARY outcome
Timeframe: Baseline, 6 months and 24 monthsPopulation: 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 3 LVAS (HM3 LVAS)
n=1685 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Six Minute Walk Test (6MWT)
Baseline
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101.3 meters
Standard Deviation 160.7
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Six Minute Walk Test (6MWT)
6 months
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317.2 meters
Standard Deviation 163.3
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Six Minute Walk Test (6MWT)
24 months
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305.1 meters
Standard Deviation 172.5
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SECONDARY outcome
Timeframe: Baseline, 6 months and 24 monthsPopulation: 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 3 LVAS (HM3 LVAS)
n=1685 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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New York Heart Association (NYHA) Classification
NYHA Class I or II at Baseline
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0 Participants
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New York Heart Association (NYHA) Classification
Class I or II at 6 Months
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1046 Participants
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New York Heart Association (NYHA) Classification
Class I or II at 24 Months
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686 Participants
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SECONDARY outcome
Timeframe: Baseline, 6 months and 24 monthsPopulation: 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 3 LVAS (HM3 LVAS)
n=1685 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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EuroQol-5D-5L Visual Analogue Scale
Baseline
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48.3 score on a scale
Standard Deviation 25.1
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EuroQol-5D-5L Visual Analogue Scale
6 months
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73.9 score on a scale
Standard Deviation 18.2
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EuroQol-5D-5L Visual Analogue Scale
24 months
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72.4 score on a scale
Standard Deviation 20.1
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SECONDARY outcome
Timeframe: Baseline, 6 months and 24 monthsPopulation: 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 3 LVAS (HM3 LVAS)
n=1685 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Baseline
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40.0 Score on a scale
Standard Deviation 21.6
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Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
6 months
|
69.5 Score on a scale
Standard Deviation 20.0
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Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
24 months
|
67.3 Score on a scale
Standard Deviation 21.8
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SECONDARY outcome
Timeframe: From initial discharge to 2 years post-implantPopulation: Subjects who were discharged on LVAD support from the implant hospitalization
Rate of all cause rehospitalization
Outcome measures
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
n=1571 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Rehospitalizations
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2.03 events per patient year
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SECONDARY outcome
Timeframe: 2 years post-implantEvents-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Outcome measures
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
n=1685 Participants
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Adverse Event Rates
Arterial Non-CNS Thromboembolism
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0.01 events per patient year
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Adverse Event Rates
Bleeding
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0.71 events per patient year
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Adverse Event Rates
Cardiac Arrhythmia
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0.30 events per patient year
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Adverse Event Rates
Hypertension
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0.04 events per patient year
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Adverse Event Rates
Major Infection
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0.73 events per patient year
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Adverse Event Rates
Myocardial Infarction
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0.01 events per patient year
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Adverse Event Rates
Stroke
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0.07 events per patient year
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Adverse Event Rates
Other Neurological Event
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0.09 events per patient year
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Adverse Event Rates
Pericardial Fluid Collection
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0.04 events per patient year
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Adverse Event Rates
Psychiatric Episode
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0.07 events per patient year
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Adverse Event Rates
Renal Dysfunction
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0.11 events per patient year
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Adverse Event Rates
Respiratory Failure
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0.16 events per patient year
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Adverse Event Rates
Right Heart Failure
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0.27 events per patient year
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Adverse Event Rates
Venous Thromboembolism
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0.03 events per patient year
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Adverse Event Rates
Wound Dehiscence
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0.00 events per patient year
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Adverse Event Rates
Suspected Device Thrombosis
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0.01 events per patient year
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Adverse Event Rates
Hemolysis
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0.00 events per patient year
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Adverse Event Rates
Hepatic Dysfunction
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0.04 events per patient year
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Adverse Events
HeartMate 3 LVAS (HM3 LVAS)
Serious events: 1536 serious events
Other events: 1050 other events
Deaths: 293 deaths
Serious adverse events
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
n=1685 participants at risk
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Blood and lymphatic system disorders
Protocol defined bleeding
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47.6%
802/1685 • 2 years post-implant
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.
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Blood and lymphatic system disorders
Protocol defined hemolysis
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0.36%
6/1685 • 2 years post-implant
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.
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Cardiac disorders
Protocol defined cardiac arrhythmia
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28.1%
473/1685 • 2 years post-implant
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.
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Cardiac disorders
Protocol defined myocardial infarction
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0.89%
15/1685 • 2 years post-implant
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.
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Cardiac disorders
Protocol defined pericardial fluid collection
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5.7%
96/1685 • 2 years post-implant
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.
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Cardiac disorders
Protocol defined right heart failure
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32.1%
541/1685 • 2 years post-implant
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.
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General disorders
Protocol defined other adverse event
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64.3%
1084/1685 • 2 years post-implant
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.
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Hepatobiliary disorders
Protocol defined hepatic dysfunction
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3.4%
58/1685 • 2 years post-implant
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.
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Infections and infestations
Protocol defined major infection
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51.2%
862/1685 • 2 years post-implant
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.
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Nervous system disorders
Protocol defined stroke
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9.1%
153/1685 • 2 years post-implant
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.
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Nervous system disorders
Protocol defined other neurological event
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12.0%
202/1685 • 2 years post-implant
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.
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Product Issues
Protocol defined suspected device thrombosis
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1.1%
18/1685 • 2 years post-implant
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.
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Psychiatric disorders
Protocol defined psychiatric episode
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4.3%
73/1685 • 2 years post-implant
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.
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Renal and urinary disorders
Protocol defined renal dysfunction
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13.7%
231/1685 • 2 years post-implant
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.
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Respiratory, thoracic and mediastinal disorders
Protocol defined respiratory failure
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19.3%
325/1685 • 2 years post-implant
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.
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Skin and subcutaneous tissue disorders
Protocol defined wound dehiscence
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0.59%
10/1685 • 2 years post-implant
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.
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Vascular disorders
Protocol defined arterial non-CNS thromboembolism
|
1.2%
21/1685 • 2 years post-implant
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.
|
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Vascular disorders
Protocol defined hypertension
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2.7%
45/1685 • 2 years post-implant
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.
|
|
Vascular disorders
Protocol defined venous thromboembolism
|
1.8%
30/1685 • 2 years post-implant
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.
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Other adverse events
| Measure |
HeartMate 3 LVAS (HM3 LVAS)
n=1685 participants at risk
Patients implanted with HeartMate 3 LVAS and enrolled in the MOMENTUM 3 CAP cohort.
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|---|---|
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Blood and lymphatic system disorders
Protocol defined bleeding
|
6.4%
107/1685 • 2 years post-implant
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.
|
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Cardiac disorders
Protocol defined cardiac arrhythmia
|
8.0%
135/1685 • 2 years post-implant
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.
|
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Infections and infestations
Protocol defined major infection
|
15.8%
267/1685 • 2 years post-implant
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.
|
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Psychiatric disorders
Protocol defined psychiatric episode
|
5.6%
94/1685 • 2 years post-implant
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.
|
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Cardiac disorders
Protocol defined right heart failure
|
6.4%
107/1685 • 2 years post-implant
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.
|
|
General disorders
Protocol defined other adverse event
|
36.6%
617/1685 • 2 years post-implant
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER