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A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) (DT2)

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ClinicalTrials.gov Identifier: NCT01966458
Recruitment Status : Active, not recruiting
First Posted : October 21, 2013
Results First Posted : April 23, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Heart Failure
Interventions Device: HeartWare® VAS (HVAD)
Device: Control LVAD
Enrollment 494
Recruitment Details  
Pre-assignment Details Subjects were considered enrolled upon signing informed consent. 19 enrolled subjects weren't randomized as they were considered screen failures. 10 subjects were randomized but didn't receive a device due to death (with 1 subject dying post anesthesia but prior to Left Ventricular Assist Device (LVAD) implant) or screen failure prior to implant.
Arm/Group Title HeartWare® Ventricular Assist System (VAS) Control Left Ventricular Assist Device (LVAD)
Hide Arm/Group Description HeartWare® Ventricular Assist System (VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use. Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.
Period Title: Overall Study
Started 308 157
Completed 304 155
Not Completed 4 2
Arm/Group Title HeartWare® VAS Control LVAD Total
Hide Arm/Group Description HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use. Control LVAD: Any FDA-approved LVAD for destination therapy. Total of all reporting groups
Overall Number of Baseline Participants 308 157 465
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 308 participants 157 participants 465 participants
63.3  (11.44) 64.2  (11.14) 63.6  (11.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 157 participants 465 participants
Female
56
  18.2%
32
  20.4%
88
  18.9%
Male
252
  81.8%
125
  79.6%
377
  81.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 157 participants 465 participants
Hispanic or Latino
20
   6.5%
3
   1.9%
23
   4.9%
Not Hispanic or Latino
288
  93.5%
154
  98.1%
442
  95.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 308 participants 157 participants 465 participants
American Indian/Alaska Native
2
   0.6%
1
   0.6%
3
   0.6%
Asian
1
   0.3%
2
   1.3%
3
   0.6%
Black/African American
72
  23.4%
33
  21.0%
105
  22.6%
Native Hawaiian/Pacific Islander
1
   0.3%
0
   0.0%
1
   0.2%
White
221
  71.8%
118
  75.2%
339
  72.9%
Other
11
   3.6%
3
   1.9%
14
   3.0%
1.Primary Outcome
Title Number of Participants With Neurologic Injury
Hide Description The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) > 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.
Time Frame Implant to 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects were excluded if they withdrew, were lost to follow-up or have missing outcomes on original device.
Arm/Group Title HeartWare® VAS Control LVAD
Hide Arm/Group Description:
HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Control LVAD: Any FDA-approved LVAD for destination therapy.
Overall Number of Participants Analyzed 306 157
Measure Type: Count of Participants
Unit of Measure: Participants
45
  14.7%
19
  12.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HeartWare® VAS, Control LVAD
Comments The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.
Type of Statistical Test Non-Inferiority
Comments A non-inferiority margin of 6% was pre-specified.
Statistical Test of Hypothesis P-Value 0.1444
Comments [Not Specified]
Method Farrington-Manning asymptotic test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.6
Confidence Interval (2-Sided) 90%
-5.5 to 10.7
Estimation Comments Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.
2.Secondary Outcome
Title Number of HeartWare VAS Participants With Stroke/TIA
Hide Description The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.
Time Frame Implant to 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects were excluded if they withdrew or were lost to follow up on the original device.
Arm/Group Title HeartWare® VAS
Hide Arm/Group Description:
HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Overall Number of Participants Analyzed 307
Measure Type: Count of Participants
Unit of Measure: Participants
59
  19.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HeartWare® VAS
Comments The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7363
Comments [Not Specified]
Method Exact Binomial Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent of Participants
Estimated Value 19.2
Confidence Interval (2-Sided) 90%
15.6 to 23.3
Estimation Comments Two-sided exact binomial confidence interval used
3.Secondary Outcome
Title Number of Participants With Stroke-Free Success
Hide Description Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale >=4).
Time Frame Implant to 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects were excluded if they had no associated 24 week post-stroke Modified Rankin Scale value, or if the subject withdrew or was lost to follow-up on original device, and no other failure outcome occurred within 1 year post original implant.
Arm/Group Title HeartWare® VAS Control LVAD
Hide Arm/Group Description:
HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Control LVAD: Any FDA-approved LVAD for destination therapy.
Overall Number of Participants Analyzed 301 157
Measure Type: Count of Participants
Unit of Measure: Participants
229
  76.1%
105
  66.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HeartWare® VAS, Control LVAD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin on the difference in success proportions is 15%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Farrington-Manning asymptotic test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -9.2
Confidence Interval (2-Sided) 90%
-17.2 to -1.1
Estimation Comments Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HeartWare® VAS, Control LVAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0354
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame The adverse events are summarized from the date of implant through 12 months while on the originally implanted device. Subjects are analyzed based on the device they actually received.
Adverse Event Reporting Description The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
 
Arm/Group Title HeartWare® VAS Control LVAD
Hide Arm/Group Description

Implant of HeartWare® Ventricular Assist System

HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.

Implant of FDA-approved LVAD approved for destination therapy

Control LVAD: Any FDA-approved LVAD for destination therapy.

All-Cause Mortality
HeartWare® VAS Control LVAD
Affected / at Risk (%) Affected / at Risk (%)
Total   56/308 (18.18%)      31/157 (19.75%)    
Show Serious Adverse Events Hide Serious Adverse Events
HeartWare® VAS Control LVAD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   295/308 (95.78%)      152/157 (96.82%)    
Blood and lymphatic system disorders     
Major Bleeding  1  156/308 (50.65%)  297 87/157 (55.41%)  190
Hemolysis  1  3/308 (0.97%)  4 8/157 (5.10%)  8
Cardiac disorders     
Cardiac Arrhythmia  1  95/308 (30.84%)  132 42/157 (26.75%)  49
Hypertension  1  27/308 (8.77%)  34 12/157 (7.64%)  12
Myocardial Infarction  1  0/308 (0.00%)  0 2/157 (1.27%)  2
Pericardial Fluid Collection  1  17/308 (5.52%)  18 13/157 (8.28%)  15
Right Heart Failure  1  94/308 (30.52%)  101 56/157 (35.67%)  61
General disorders     
Other Intermacs  1  219/308 (71.10%)  599 106/157 (67.52%)  265
Hepatobiliary disorders     
Hepatic Dysfunction  1  10/308 (3.25%)  10 6/157 (3.82%)  6
Infections and infestations     
Major Infection  1  150/308 (48.70%)  259 85/157 (54.14%)  149
Nervous system disorders     
Neurological Dysfunction  1  57/308 (18.51%)  83 24/157 (15.29%)  26
Product Issues     
Device Malfunction/Failure  1  60/308 (19.48%)  81 38/157 (24.20%)  46
Psychiatric disorders     
Psychiatric Episode  1  34/308 (11.04%)  35 11/157 (7.01%)  12
Renal and urinary disorders     
Renal Dysfunction  1  32/308 (10.39%)  35 23/157 (14.65%)  25
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure  1  61/308 (19.81%)  74 31/157 (19.75%)  37
Skin and subcutaneous tissue disorders     
Wound Dehiscence  1  1/308 (0.32%)  1 1/157 (0.64%)  1
Vascular disorders     
Arterial Non-CNS Thromboembolism  1  3/308 (0.97%)  3 0/157 (0.00%)  0
Venous Thromboembolism  1  11/308 (3.57%)  11 4/157 (2.55%)  5
1
Term from vocabulary, Intermacs Ver. 3.0
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%
HeartWare® VAS Control LVAD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   95/308 (30.84%)      40/157 (25.48%)    
Cardiac disorders     
Cardiac Arrhythmia  1  16/308 (5.19%)  19 7/157 (4.46%)  7
Hypertension  1  16/308 (5.19%)  20 8/157 (5.10%)  9
General disorders     
Other Intermacs  1  29/308 (9.42%)  30 8/157 (5.10%)  8
Infections and infestations     
Major Infection  1  33/308 (10.71%)  41 24/157 (15.29%)  32
Product Issues     
Device Malfunction/Failure  1  18/308 (5.84%)  26 1/157 (0.64%)  1
1
Term from vocabulary, Intermacs Ver. 3.0
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.
In most cases, the contract allows the principal investigator to publish their data after the release of the multi-center publication (or one year after the conclusion of the study if no multi-center publication is submitted) following the sponsor review for (a) disclosure of confidential information, and (b) information that would impair the sponsor’s ability to obtain patent protection.
Results Point of Contact
Name/Title: Thomas Vassiliades
Organization: Medtronic
Phone: +15085321942
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01966458     History of Changes
Other Study ID Numbers: HW004-A
First Submitted: October 17, 2013
First Posted: October 21, 2013
Results First Submitted: February 12, 2018
Results First Posted: April 23, 2018
Last Update Posted: May 30, 2018