Trial Outcomes & Findings for HeartMate 3™ CE Mark Clinical Investigation Plan (NCT NCT02170363)
NCT ID: NCT02170363
Last Updated: 2022-06-27
Results Overview
Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2022-06-27
Participant Flow
50 patients were recruited at 10 cardiac transplant centers and implanted between June 25, 2014, and November 27, 2014
The data presented in this record includes all 50 patients followed through to the 6-month primary endpoint.
Participant milestones
| Measure |
HeartMate 3
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HeartMate 3™ CE Mark Clinical Investigation Plan
Baseline characteristics by cohort
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Age, Continuous
|
58.9 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Kazakhstan
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=5 Participants
|
|
Body Surface Area
|
2 M^2
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Cardiac Index
|
1.8 L/min/m^2
STANDARD_DEVIATION 0.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All 50 patients were analyzed when the last patient reached the 6-month primary endpoint on May 26, 2015
Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Survival
|
92 Percentage of Participants who Survived
Interval 83.0 to 97.0
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6Population: Patients alive and capable of performing the test at 6 months
The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Quality of Life (EQ-5D-5L)
Baseline
|
50 Units on a EQ-5D-5L Score scale
Interval 12.0 to 90.0
|
|
Quality of Life (EQ-5D-5L)
Month 1
|
60 Units on a EQ-5D-5L Score scale
Interval 10.0 to 95.0
|
|
Quality of Life (EQ-5D-5L)
Month 3
|
70 Units on a EQ-5D-5L Score scale
Interval 30.0 to 100.0
|
|
Quality of Life (EQ-5D-5L)
Month 6
|
75 Units on a EQ-5D-5L Score scale
Interval 29.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6Population: Only patients alive, capable and willing to perform test are included.
The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Functional Status - Six Minute Walk Test (6MWT)
Month 6
|
385 meters
Interval 70.0 to 705.0
|
|
Functional Status - Six Minute Walk Test (6MWT)
Baseline
|
236 meters
Interval 5.0 to 550.0
|
|
Functional Status - Six Minute Walk Test (6MWT)
Month 1
|
260 meters
Interval 21.1 to 582.0
|
|
Functional Status - Six Minute Walk Test (6MWT)
Month 3
|
375 meters
Interval 35.0 to 671.0
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6Population: Only patients alive, capable and willing to perform test are included.
NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Functional Status - New York Heart Association (NYHA) Classification
Baseline NYHA I or II
|
0 percentage of participants
|
|
Functional Status - New York Heart Association (NYHA) Classification
Baseline NYHA III or IV
|
100 percentage of participants
|
|
Functional Status - New York Heart Association (NYHA) Classification
Month 1 NYHA I or II
|
64 percentage of participants
|
|
Functional Status - New York Heart Association (NYHA) Classification
Month 1 NYHA III or IV
|
36 percentage of participants
|
|
Functional Status - New York Heart Association (NYHA) Classification
Month 3 NYHA 1 or II
|
81 percentage of participants
|
|
Functional Status - New York Heart Association (NYHA) Classification
Month 3 NYHA III or IV
|
19 percentage of participants
|
|
Functional Status - New York Heart Association (NYHA) Classification
Month 6 NYHA I or II
|
83 percentage of participants
|
|
Functional Status - New York Heart Association (NYHA) Classification
Month 6 NYHA III or IV
|
17 percentage of participants
|
SECONDARY outcome
Timeframe: As they occurred, Baseline through 180 DaysFrequency of pre-defined anticipated adverse events
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
All Adverse Events
Bleeding
|
38 % of Participants with Adverse Events
|
|
All Adverse Events
Bleeding requiring surgery
|
14 % of Participants with Adverse Events
|
|
All Adverse Events
Gastrointestinal bleeding
|
8 % of Participants with Adverse Events
|
|
All Adverse Events
Cardiac Arrhythmia
|
34 % of Participants with Adverse Events
|
|
All Adverse Events
Pericardial fluid
|
2 % of Participants with Adverse Events
|
|
All Adverse Events
Internal device malfunction
|
6 % of Participants with Adverse Events
|
|
All Adverse Events
Pump thrombosis
|
0 % of Participants with Adverse Events
|
|
All Adverse Events
External device malfunctions
|
24 % of Participants with Adverse Events
|
|
All Adverse Events
Hemolysis
|
0 % of Participants with Adverse Events
|
|
All Adverse Events
Hepatic dysfunction
|
2 % of Participants with Adverse Events
|
|
All Adverse Events
Hypertension
|
2 % of Participants with Adverse Events
|
|
All Adverse Events
Any infection
|
36 % of Participants with Adverse Events
|
|
All Adverse Events
Infection - sepsis
|
16 % of Participants with Adverse Events
|
|
All Adverse Events
Infection - driveline
|
10 % of Participants with Adverse Events
|
|
All Adverse Events
Myocardial infarction
|
0 % of Participants with Adverse Events
|
|
All Adverse Events
Any stroke
|
12 % of Participants with Adverse Events
|
|
All Adverse Events
Stroke - ischemic
|
8 % of Participants with Adverse Events
|
|
All Adverse Events
Stroke - hemorrhagic
|
4 % of Participants with Adverse Events
|
|
All Adverse Events
Neurologic dysfunction
|
8 % of Participants with Adverse Events
|
|
All Adverse Events
Psychiatric episode
|
6 % of Participants with Adverse Events
|
|
All Adverse Events
Renal dysfunction
|
10 % of Participants with Adverse Events
|
|
All Adverse Events
Respiratory failure
|
16 % of Participants with Adverse Events
|
|
All Adverse Events
Right heart failure
|
10 % of Participants with Adverse Events
|
|
All Adverse Events
Right heart failure w RVAD
|
4 % of Participants with Adverse Events
|
|
All Adverse Events
Wound dehiscence
|
8 % of Participants with Adverse Events
|
|
All Adverse Events
Other
|
54 % of Participants with Adverse Events
|
SECONDARY outcome
Timeframe: As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcomeFrequency and incidence of device malfunction
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Device Malfunctions
Pump malfunctions
|
0 Number of events
|
|
Device Malfunctions
Non-pump malfunction: internal component
|
3 Number of events
|
|
Device Malfunctions
Non-pump malfunction: External components
|
14 Number of events
|
SECONDARY outcome
Timeframe: As they occurred, Baseline through 180 DaysPopulation: Twenty-nine (58%) did not have reoperation
Frequency of reoperations
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Reoperations
Major bleeding
|
11 Number of re-operations by reason
|
|
Reoperations
Cardiac arrhythmia
|
1 Number of re-operations by reason
|
|
Reoperations
Pericardial fluid
|
1 Number of re-operations by reason
|
|
Reoperations
Major infection
|
3 Number of re-operations by reason
|
|
Reoperations
Respiratory failure
|
4 Number of re-operations by reason
|
|
Reoperations
Right heart failure
|
3 Number of re-operations by reason
|
|
Reoperations
Wound dehiscence
|
15 Number of re-operations by reason
|
|
Reoperations
Other
|
23 Number of re-operations by reason
|
SECONDARY outcome
Timeframe: As they occurred, Baseline through 180 DaysPopulation: Number of Participants with Rehospitalizations According to Rehospitalization Type
Frequency and incidence of rehospitalizations
Outcome measures
| Measure |
HeartMate 3
n=43 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Rehospitalizations
Suspected device malfunction
|
1 Participants
|
|
Rehospitalizations
Transplant/ Transplant evaluation
|
1 Participants
|
|
Rehospitalizations
Anticoagulation maintenance
|
1 Participants
|
|
Rehospitalizations
Routine testing
|
1 Participants
|
|
Rehospitalizations
ICD therapy
|
1 Participants
|
|
Rehospitalizations
Suspected driveline infection
|
1 Participants
|
|
Rehospitalizations
Bleeding
|
4 Participants
|
|
Rehospitalizations
Infection
|
6 Participants
|
|
Rehospitalizations
Neurologic dysfunction
|
1 Participants
|
|
Rehospitalizations
Arrythmia
|
1 Participants
|
|
Rehospitalizations
Volume issue
|
3 Participants
|
|
Rehospitalizations
INR
|
5 Participants
|
|
Rehospitalizations
Chest pain
|
2 Participants
|
|
Rehospitalizations
Other
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of participants free of debilitating stroke (Modified Rankin Score \> 3)
Outcome measures
| Measure |
HeartMate 3
n=50 Participants
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
|
|---|---|
|
Stroke Free Survival
|
90 percentage of participants
|
Adverse Events
HeartMate 3
Serious events: 34 serious events
Other events: 34 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
HeartMate 3
n=50 participants at risk
Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
|
|---|---|
|
General disorders
Bleeding
|
28.0%
14/50 • Number of events 19 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Blood and lymphatic system disorders
Bleeding - Requiring Surgery
|
14.0%
7/50 • Number of events 8 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Blood and lymphatic system disorders
Bleeding - Gastrointestinal
|
8.0%
4/50 • Number of events 6 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Cardiac Arrhythmias - Ventricular
|
12.0%
6/50 • Number of events 6 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Cardiac Arrhythmias - Supraventricular
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Pericardial Fluid
|
2.0%
1/50 • Number of events 1 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Surgical and medical procedures
Internal Device Malfunction
|
2.0%
1/50 • Number of events 1 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Product Issues
Pump Thrombosis
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Product Issues
External Device Malfunctions
|
2.0%
1/50 • Number of events 1 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Infections and infestations
Any Infection
|
22.0%
11/50 • Number of events 13 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Infections and infestations
Infection - Sepsis
|
12.0%
6/50 • Number of events 6 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Infections and infestations
Infection - Driveline
|
6.0%
3/50 • Number of events 3 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Infections and infestations
Infection - Pump
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Nervous system disorders
Any Stroke
|
12.0%
6/50 • Number of events 6 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Nervous system disorders
Stroke - Ischemic
|
8.0%
4/50 • Number of events 4 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Nervous system disorders
Stroke - Hemorrhagic
|
4.0%
2/50 • Number of events 2 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Nervous system disorders
Neurologic Dysfunction
|
2.0%
1/50 • Number of events 1 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Psychiatric disorders
Psychiatric Episode
|
2.0%
1/50 • Number of events 1 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Renal and urinary disorders
Renal Dysfunction
|
6.0%
3/50 • Number of events 3 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.0%
8/50 • Number of events 8 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Right Heart Failure
|
8.0%
4/50 • Number of events 4 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Right Heart Failure - requiring RVAD
|
4.0%
2/50 • Number of events 2 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Blood and lymphatic system disorders
Arterial Thromboembolism
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Blood and lymphatic system disorders
Venous Thromboembolism
|
0.00%
0/50 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
6.0%
3/50 • Number of events 3 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
General disorders
Other Serious Adverse Event
|
34.0%
17/50 • Number of events 24 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
Other adverse events
| Measure |
HeartMate 3
n=50 participants at risk
Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
|
|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
10.0%
5/50 • Number of events 16 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Cardiac Arrhythmias
|
22.0%
11/50 • Number of events 11 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Cardiac disorders
Cardiac Arrhythmias - Supraventricular
|
20.0%
10/50 • Number of events 10 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Product Issues
External Device Malfunction
|
22.0%
11/50 • Number of events 13 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Infections and infestations
Any infection
|
14.0%
7/50 • Number of events 15 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
Nervous system disorders
Neurologic Dysfunction
|
6.0%
3/50 • Number of events 3 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
|
General disorders
Other Non-serious Adverse Event
|
20.0%
10/50 • Number of events 36 • From time of device implant to 6 months
Adverse events were documented by study site staff as they occurred per protocol definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60