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Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

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ClinicalTrials.gov Identifier: NCT00121472
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : March 19, 2013
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Corporation )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Failure, Congestive
Ventricular Dysfunction
Cardiomyopathies
Intervention Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)
Enrollment 194

Recruitment Details 486 patients were recruited at 36 cardiac transplantation hospitals between 8 Mar 2005 and 21 Apr 2008. After enrolling the initial 133 patients prespecified by the study protocol, an additional 353 patients were enrolled under a Continued Access Protocol(CAP) and in a concurrent Canadian study.
Pre-assignment Details 194 patients were followed to at least 1 year after implantation of the device, all 133 of the Pivotal Study Cohort patients and 61 of the US CAP patients, results of which are summarized below and in the final FDA-approved labeling for the HeartMate II LVAS. The remaining 292 patients followed for less than 1 year are not included.
Arm/Group Title HeartMate II (HMII)
Hide Arm/Group Description HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).
Period Title: Overall Study
Started 194
Completed 194 [1]
Not Completed 0
[1]
Followed for at least 1 year after implantation of HM II LVAS.
Arm/Group Title HM II
Hide Arm/Group Description HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
Overall Number of Baseline Participants 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants
50.6  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants
Female
44
  22.7%
Male
150
  77.3%
Body Surface Area   [1] 
Mean (Standard Deviation)
Unit of measure:  Sq. meter
Number Analyzed 194 participants
1.99  (0.29)
[1]
Measure Description: Body Surface Area (BSA) calculated from patients height and weight
Cardiac Index  
Mean (Standard Deviation)
Unit of measure:  L/min/m^2
Number Analyzed 194 participants
2.0  (0.5)
PCWP   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 194 participants
26.0  (7.7)
[1]
Measure Description: Pulmonary capillary wedge pressure
1.Primary Outcome
Title Survival
Hide Description Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).
Time Frame 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).
Arm/Group Title HM II
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: participants
Transplanted 112
Myocardial recovery, device removed 6
Alive on device at 180 days & UNOS Status 1A or 1B 18
Alive on device at 180 days, not Status 1A or 1B 19
Received other ventricular assist device 3
Expired prior to 180 days while on VAD support 36
2.Secondary Outcome
Title Clinical Reliability (Malfunctions/Failures)
Hide Description Confirmed malfunctions/Serious Adverse Events
Time Frame continuous
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HM II
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: Number of Serious Events
Pump 7
Inflow Cannula 2
Outflow Cannula 2
System Controller 10
System Monitor 0
Display Module 0
Power Base Unit 0
Power Base Unit Cable 1
Batteries 1
Battery Clips 0
Shower Kit 0
Surgical Accessories 0
3.Secondary Outcome
Title Kansas City Cardiomyopathy Questionaire (KCCQ)
Hide Description KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
Time Frame baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients alive and capable of performing the test at 6 months
Arm/Group Title HMII
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
Overall Number of Participants Analyzed 53
Mean (Standard Error)
Unit of Measure: Units on a KCCQ Score scale
KCCQ Overall Summary Score (OSS) 29.5  (2.7)
KCCQ Clinical Summary Score (CSS) 28.8  (2.4)
4.Secondary Outcome
Title New York Heart Association (NYHA) Classification
Hide Description NYHA 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, 1 month, 3 months, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who survived to interval are included.
Arm/Group Title HM II
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Overall Number of Participants Analyzed 194
Mean (Full Range)
Unit of Measure: units on NYHA scale
Baseline NYHA Class
4.0
(3 to 4)
Month 1 NYHA Class
2.2
(1 to 4)
Month 3 NYHA Class
1.8
(1 to 4)
Month 6 NYHA Class
1.7
(1 to 3)
5.Secondary Outcome
Title Minnesota Living With Heart Failure Questionnaire (MLWHF)
Hide Description MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.
Time Frame Baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients alive and capable of performing the test at 6 months
Arm/Group Title HMII
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Overall Number of Participants Analyzed 52
Mean (Standard Error)
Unit of Measure: units on a MLWHF Score scale
-32.3  (2.9)
6.Secondary Outcome
Title 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 to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline in 6MWT distance at Month 1, 3, and 6. Only patients alive, capable and willing to perform test are included.
Arm/Group Title HMII
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Overall Number of Participants Analyzed 194
Mean (Standard Error)
Unit of Measure: meters
Month 1 (N = 151) 149.2  (14.5)
Month 3 (N = 101) 235.4  (22.0)
Month 6 (N = 64) 296.8  (27.8)
7.Secondary Outcome
Title Reoperations
Hide Description Additional surgery after the initial implant operation
Time Frame continuous
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).
Arm/Group Title HMII Replacement
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: Number of Events
HMII Replacement 8
Bleeding 104
Mediastinal exploration, evacuation and chest clos 7
Chest closure or reinforcement of closure 32
ICD placement or exchange 8
Evacuation of pericardial effusion 1
RVAD placemant or removal 9
Tracheostomy 9
Cholecystectomy, feeding tube placement, tracheost 1
Evacuation of pleural effusion, dialysis catheter 1
Feeding tube placement, chest tube placement 1
Left lower lobe wedge resection 1
LVAD evaluation and repair 2
Mediastinal exploration and evacuation 1
Mediastinal exploration , wound debridement, ICD r 1
Placement of chest tubes 1
Removal of foreign body 1
Total abdominal cholectomy with end-ileostomy 1
Device explant 1
Feeding tube placement 1
Mediastinal exploration, chest closure, gortex gra 2
Mediastinal exploration , evacuation, pacemaker re 1
Pericardial window 1
8.Secondary Outcome
Title Post-transplant Survival
Hide Description 30 day and 1 year post transplant survival
Time Frame 30 days, 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients (n=112) who recieved a cardiac transplant were followed at 30 day and 1 year post-transplant to determine if the device influenced post-transplant survival.
Arm/Group Title HM II
Hide Arm/Group Description:
HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of participants
Survival at 30 days (%) 96
Survival at 1 year (%) 87
Time Frame From time of device implant to time of cardiac transplantation, permanent device removal, or death.
Adverse Event Reporting Description Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
 
Arm/Group Title HMII
Hide Arm/Group Description HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
All-Cause Mortality
HMII
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HMII
Affected / at Risk (%) # Events
Total   194/194 (100.00%)    
Blood and lymphatic system disorders   
Bleeding requiring surgery  1  56/194 (28.87%)  64
Device thrombosis  1  3/194 (1.55%)  3
Hemolysis  1  6/194 (3.09%)  6
Peripheral Thromboembolism  1  10/194 (5.15%)  11
Cardiac disorders   
Right heart failure  1  36/194 (18.56%)  37
Cardiac arrhythmias  1  82/194 (42.27%)  135
Myocardial infarction  1  2/194 (1.03%)  2
General disorders   
Bleeding  1  117/194 (60.31%)  225
Hepatobiliary disorders   
Hepatic dysfunction  1  3/194 (1.55%)  3
Infections and infestations   
Driveline infection  1  16/194 (8.25%)  20
Pocket infection  1  4/194 (2.06%)  4
Sepsis  1  35/194 (18.04%)  47
Local infection  1  45/194 (23.20%)  74
Nervous system disorders   
Stroke  1  17/194 (8.76%)  19
Other neurological  1 [1]  15/194 (7.73%)  18
Psychiatric disorders   
Psychological  1  3/194 (1.55%)  5
Renal and urinary disorders   
Renal failure  1  25/194 (12.89%)  26
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  53/194 (27.32%)  66
Indicates events were collected by systematic assessment
1
Term from vocabulary, Protocol and CEC
[1]
Includes transient ischemic attachs (TIA) and non-stroke neurological events.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HMII
Affected / at Risk (%) # Events
Total   36/194 (18.56%)    
General disorders   
Bleeding  1 [1]  16/194 (8.25%)  50
Localized Infection  1 [2]  15/194 (7.73%)  44
Driveline Infection  1 [3]  10/194 (5.15%)  16
Cardiac Arrhythmias  1 [4]  29/194 (14.95%)  69
Psychological  1 [5]  10/194 (5.15%)  10
Device Malfunctions  1 [6]  36/194 (18.56%)  61
Indicates events were collected by systematic assessment
1
Term from vocabulary, Protocol and CEC
[1]
Non-serious bleeding events
[2]
Non-serious localized infection
[3]
Non-serious driveline infection
[4]
Non-serious cardiac arrhythmias
[5]
Non-serious psychological
[6]
Non-serious device malfunctions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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, MD, MBA, Sr. Director, Clinical Affairs
Organization: Thoratec Corporation
Phone: (781) 852-8334
Responsible Party: St. Jude Medical ( Thoratec Corporation )
ClinicalTrials.gov Identifier: NCT00121472     History of Changes
Other Study ID Numbers: TC010230-1
First Submitted: July 12, 2005
First Posted: July 21, 2005
Results First Submitted: May 29, 2009
Results First Posted: March 19, 2013
Last Update Posted: May 13, 2016