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HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02170363
Recruitment Status : Active, not recruiting
First Posted : June 23, 2014
Results First Posted : February 15, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Center for Life Sciences
Emergo
KCRI
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Refractory Left Ventricular Heart Failure
Intervention Device: Left Ventricular Assist System (LVAS)
Enrollment 50
Recruitment Details 50 patients were recruited at 10 cardiac transplant centers and implanted between June 25, 2014, and November 27, 2014
Pre-assignment Details The data presented in this record includes all 50 patients followed through to the 6-month primary endpoint.
Arm/Group Title HeartMate 3
Hide Arm/Group Description HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Period Title: Overall Study
Started 50
Completed 50 [1]
Not Completed 0
[1]
Followed to the 6-Month Primary Endpoint
Arm/Group Title HeartMate 3
Hide Arm/Group Description HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
58.9  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
5
  10.0%
Male
45
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
Canada 3
Austria 7
Czech Republic 10
Australia 1
Kazakhstan 8
Germany 21
Body Surface Area   [1] 
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 50 participants
2  (0.2)
[1]
Measure Description: Body Surface Area (BSA) calculated from patients height and weight
Cardiac Index   [1] 
Mean (Standard Deviation)
Unit of measure:  L/min/m^2
Number Analyzed 50 participants
1.8  (0.5)
[1]
Measure Description: Cardiac index (CI) is a hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA), thus relating heart performance to the size of the individual. Values less than 2.2 L/min/m^2 indicate that the patient may be in cardiogenic shock.
1.Primary Outcome
Title Survival
Hide Description Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 50 patients were analyzed when the last patient reached the 6-month primary endpoint on May 26, 2015
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Percentage of Participants who Survived
92
(83 to 97)
2.Secondary Outcome
Title Quality of Life (EQ-5D-5L)
Hide Description 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.
Time Frame Baseline, Month 1, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Patients alive and capable of performing the test at 6 months
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
Overall Number of Participants Analyzed 50
Median (Full Range)
Unit of Measure: Units on a EQ-5D-5L Score scale
Baseline Number Analyzed 43 participants
50
(12 to 90)
Month 1 Number Analyzed 43 participants
60
(10 to 95)
Month 3 Number Analyzed 43 participants
70
(30 to 100)
Month 6 Number Analyzed 40 participants
75
(29 to 100)
3.Secondary Outcome
Title Functional Status - Six Minute Walk Test (6MWT)
Hide Description 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.
Time Frame Baseline, Month 1, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients alive, capable and willing to perform test are included.
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
Overall Number of Participants Analyzed 50
Median (Full Range)
Unit of Measure: meters
Baseline Number Analyzed 50 participants
236
(5 to 550)
Month 1 Number Analyzed 49 participants
260
(21.1 to 582)
Month 3 Number Analyzed 47 participants
375
(35 to 671)
Month 6 Number Analyzed 44 participants
385
(70 to 705)
4.Secondary Outcome
Title Functional Status - New York Heart Association (NYHA) Classification
Hide Description 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
Time Frame Baseline, Month 1, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients alive, capable and willing to perform test are included.
Arm/Group Title HeartMate 3
Hide Arm/Group Description:

Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure

Left Ventricular Assist System (LVAS): Implantation of left ventricular assist device for hemodynamic support

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
Baseline NYHA I or II Number Analyzed 50 participants
0
Baseline NYHA III or IV Number Analyzed 50 participants
100
Month 1 NYHA I or II Number Analyzed 44 participants
64
Month 1 NYHA III or IV Number Analyzed 44 participants
36
Month 3 NYHA 1 or II Number Analyzed 43 participants
81
Month 3 NYHA III or IV Number Analyzed 43 participants
19
Month 6 NYHA I or II Number Analyzed 42 participants
83
Month 6 NYHA III or IV Number Analyzed 42 participants
17
5.Secondary Outcome
Title All Adverse Events
Hide Description Frequency of pre-defined anticipated adverse events
Time Frame As they occurred, Baseline through 180 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: % of Participants with Adverse Events
Bleeding 38
Bleeding requiring surgery 14
Gastrointestinal bleeding 8
Cardiac Arrhythmia 34
Pericardial fluid 2
Internal device malfunction 6
Pump thrombosis 0
External device malfunctions 24
Hemolysis 0
Hepatic dysfunction 2
Hypertension 2
Any infection 36
Infection - sepsis 16
Infection - driveline 10
Myocardial infarction 0
Any stroke 12
Stroke - ischemic 8
Stroke - hemorrhagic 4
Neurologic dysfunction 8
Psychiatric episode 6
Renal dysfunction 10
Respiratory failure 16
Right heart failure 10
Right heart failure w RVAD 4
Wound dehiscence 8
Other 54
6.Secondary Outcome
Title Device Malfunctions
Hide Description Frequency and incidence of device malfunction
Time Frame 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 outcome
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Number of events
Pump malfunctions 0
Non-pump malfunction: internal component 3
Non-pump malfunction: External components 14
7.Secondary Outcome
Title Reoperations
Hide Description Frequency of reoperations
Time Frame As they occurred, Baseline through 180 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Twenty-nine (58%) did not have reoperation
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Number of re-operations by reason
Major bleeding 11
Cardiac arrhythmia 1
Pericardial fluid 1
Major infection 3
Respiratory failure 4
Right heart failure 3
Wound dehiscence 15
Other 23
8.Secondary Outcome
Title Rehospitalizations
Hide Description Frequency and incidence of rehospitalizations
Time Frame As they occurred, Baseline through 180 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with Rehospitalizations According to Rehospitalization Type
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
Suspected device malfunction
1
   2.3%
Transplant/ Transplant evaluation
1
   2.3%
Anticoagulation maintenance
1
   2.3%
Routine testing
1
   2.3%
ICD therapy
1
   2.3%
Suspected driveline infection
1
   2.3%
Bleeding
4
   9.3%
Infection
6
  14.0%
Neurologic dysfunction
1
   2.3%
Arrythmia
1
   2.3%
Volume issue
3
   7.0%
INR
5
  11.6%
Chest pain
2
   4.7%
Other
9
  20.9%
9.Secondary Outcome
Title Stroke Free Survival
Hide Description Percentage of participants free of debilitating stroke (Modified Rankin Score > 3)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HeartMate 3
Hide Arm/Group Description:
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) used for advanced refractory left ventricular heart failure (50 Subjects in the Study Cohort).
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
90
Time Frame From time of device implant to 6 months
Adverse Event Reporting Description Adverse events were documented by study site staff as they occurred per protocol definitions.
 
Arm/Group Title HeartMate 3
Hide Arm/Group Description Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
All-Cause Mortality
HeartMate 3
Affected / at Risk (%)
Total   4/50 (8.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
HeartMate 3
Affected / at Risk (%) # Events
Total   34/50 (68.00%)    
Blood and lymphatic system disorders   
Bleeding - Requiring Surgery  1  7/50 (14.00%)  8
Bleeding - Gastrointestinal  1  4/50 (8.00%)  6
Hemolysis  1  0/50 (0.00%)  0
Arterial Thromboembolism  1  0/50 (0.00%)  0
Venous Thromboembolism  1  0/50 (0.00%)  0
Cardiac disorders   
Cardiac Arrhythmias - Ventricular  1  6/50 (12.00%)  6
Cardiac Arrhythmias - Supraventricular  1  0/50 (0.00%)  0
Pericardial Fluid  1  1/50 (2.00%)  1
Hypertension  1  0/50 (0.00%)  0
Myocardial Infarction  1  0/50 (0.00%)  0
Right Heart Failure  1  4/50 (8.00%)  4
Right Heart Failure - requiring RVAD  1  2/50 (4.00%)  2
General disorders   
Bleeding  1  14/50 (28.00%)  19
Other Serious Adverse Event  1  17/50 (34.00%)  24
Hepatobiliary disorders   
Hepatic Dysfunction  1  0/50 (0.00%)  0
Infections and infestations   
Any Infection  1  11/50 (22.00%)  13
Infection - Sepsis  1  6/50 (12.00%)  6
Infection - Driveline  1  3/50 (6.00%)  3
Infection - Pump  1  0/50 (0.00%)  0
Nervous system disorders   
Any Stroke  1  6/50 (12.00%)  6
Stroke - Ischemic  1  4/50 (8.00%)  4
Stroke - Hemorrhagic  1  2/50 (4.00%)  2
Neurologic Dysfunction  1  1/50 (2.00%)  1
Product Issues   
Pump Thrombosis  1  0/50 (0.00%)  0
External Device Malfunctions  1  1/50 (2.00%)  1
Psychiatric disorders   
Psychiatric Episode  1  1/50 (2.00%)  1
Renal and urinary disorders   
Renal Dysfunction  1  3/50 (6.00%)  3
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure  1  8/50 (16.00%)  8
Skin and subcutaneous tissue disorders   
Wound Dehiscence  1  3/50 (6.00%)  3
Surgical and medical procedures   
Internal Device Malfunction  1  1/50 (2.00%)  1
1
Term from vocabulary, Protocol
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HeartMate 3
Affected / at Risk (%) # Events
Total   34/50 (68.00%)    
Blood and lymphatic system disorders   
Bleeding  1  5/50 (10.00%)  16
Cardiac disorders   
Cardiac Arrhythmias  1  11/50 (22.00%)  11
Cardiac Arrhythmias - Supraventricular  1  10/50 (20.00%)  10
General disorders   
Other Non-serious Adverse Event  1  10/50 (20.00%)  36
Infections and infestations   
Any infection  1  7/50 (14.00%)  15
Nervous system disorders   
Neurologic Dysfunction  1  3/50 (6.00%)  3
Product Issues   
External Device Malfunction  1  11/50 (22.00%)  13
1
Term from vocabulary, Protocol
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Poornima Sood
Organization: St. Jude Medical
Phone: +17818528334
EMail: PSood@sjm.com
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02170363     History of Changes
Other Study ID Numbers: TC02212014
First Submitted: June 19, 2014
First Posted: June 23, 2014
Results First Submitted: April 21, 2017
Results First Posted: February 15, 2018
Last Update Posted: January 30, 2019