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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160054 S008/ PAS001 |
| Date Original Protocol Accepted |
01/18/2019
|
| Date Current Protocol Accepted |
|
| Study Name |
Continued f/u of Premarket Pivotal Cohort
|
| Device Name |
HeartMate 3 Left Ventricular Assist System
|
| Clinical Trial Number(s) |
NCT02224755
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To characterize the clinical outcomes through 5 years post implantation by continuing to follow the premarket pivotal cohort of patients.
|
| Study Population |
Subjects (both HeartMate 3 and HeartMate II) who were enrolled in the premarket pivotal cohort.
|
| Sample Size |
All living subjects (about 533).
|
| Key Study Endpoints |
The composite endpoint of survival to transplant or recovery, or
on left ventricular assist device (LVAD) support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump; mortality; bleeding; major infection; hemolysis; device thrombosis; neurological dysfunction; and any other serious adverse events; as well as New York Heart Association (NYHA) classification and 6-minute walk distance (6MWD).
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
295 subjects enrolled
|
| Actual Number of Sites Enrolled |
53
|
| Patient Follow-up Rate |
The follow-up rate through 5 years was 98.67%.
|
| Final Safety Findings |
Survival Free of Debilitating Stroke or Reoperation at 5 years The Kaplan- Meier estimate of survival free of debilitating stroke or
reoperation to replace the pump was higher for the HM3 LVAS (69.7%) compared to the HMII LVAS (41.9%).
Survival and Subject Outcomes at 5 years
The number of at risk subjects is reduced for both HM3 (134) and HMII (82) subjects. The percent survived for HM3 is 73.7% and HMII 55.6%.
The sponsor reports subjects with HM3 LVAD have a statistically significant higher, p=0.0001, survival rate than subjects with HMII.
Subgroup Analyses
There was no difference in outcomes based on gender. The sponsor reports male and female subjects who received HM3 had statistically
significant higher, p<0.0001, survival free of debilitating stroke or reoperation than subjects receiving HMII. In addition the sponsor
reports for INTERMACS 1-2 and 3-7 profiles, subjects who received HM3 had statistically significant higher survival (p=0.0223
INTERMACS 1-2, p<0.0001 INTERMACS 3-7) free of debilitating stroke or reoperation than subjects receiving HMII.
Device related SAEs
The sponsor reports HM3 had significantly less bleeding (p<0.001), stroke (p=0.035) and confirmed device thrombosis events (p<0.001)
than HMII subjects. Although, the sponsor reports significantly less bleeding with the HM3, bleeding and major infection are still a risk.
Major Infection HMII: # of subjects 34; % of subjects 29.1%; # of events 67; EPPY 0.228, HM3: # of subjects 70; % of subjects 39.3%; #
of events 122; EPPY 0.263, p- value 0.348 Bleeding HMII: # of subjects 38; % of subjects 32.5%; # of events 124;
EPPY 0.4228, HM3: # of subjects 50; % of subjects 28.1%; # of events 99; EPPY 0.213, p- value <0.001
|
| Final Effect Findings |
The NYHA classification and six-minute walk distance assessments were not completed consistently at follow-up visits. Limited data
points and comparisons can be made. Overall, both HM3 and HMII subjects had improvements in NYHA classification and 6MWD
assessment throughout the 5 year follow-up compared to baseline.
|
| Study Strengths & Weaknesses |
This extended follow-up study provides continued evaluation through five years post implant on the safety and effectiveness of the HM3
LVAS. The study provides additional data on the composite endpoint as well as mortality, bleeding, major infection, hemolysis, device
thrombosis, neurological dysfunction, device related serious adverse events and functional status. Of note, there was delayed site activation,
sites declined to participate, not all subjects reconsented from the MOMENTUM 3 IDE and the COVID-19 pandemic, which attributed to
data not being collected and impact the results.
|
| Recommendations for Labeling Changes |
A labeling update will be requested to add five-year performance data to inform clinicians and patients of benefit risk profile for the device
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