Trial Outcomes & Findings for A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) (NCT NCT01966458)

NCT ID: NCT01966458

Last Updated: 2020-10-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

494 participants

Primary outcome timeframe

Implant to 12 Months

Results posted on

2020-10-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	HeartWare® Ventricular Assist System (VAS) 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) Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.
Overall Study STARTED	308	157
Overall Study COMPLETED	304	155
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeartWare® VAS n=308 Participants 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 n=157 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.	Total n=465 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 11.44 • n=5 Participants	64.2 years STANDARD_DEVIATION 11.14 • n=7 Participants	63.6 years STANDARD_DEVIATION 11.34 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	32 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	252 Participants n=5 Participants	125 Participants n=7 Participants	377 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	3 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	288 Participants n=5 Participants	154 Participants n=7 Participants	442 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian/Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black/African American	72 Participants n=5 Participants	33 Participants n=7 Participants	105 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian/Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	221 Participants n=5 Participants	118 Participants n=7 Participants	339 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Implant to 12 Months

Population: Subjects were excluded if they withdrew, were lost to follow-up or have missing outcomes on original device.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=306 Participants 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 n=157 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Number of Participants With Neurologic Injury	45 Participants	19 Participants

SECONDARY outcome

Timeframe: Implant to 12 Months

Population: Subjects were excluded if they withdrew or were lost to follow up on the original device.

The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=307 Participants 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 Control LVAD: Any FDA-approved LVAD for destination therapy.
Number of HeartWare VAS Participants With Stroke/TIA	59 Participants	—

SECONDARY outcome

Timeframe: Implant to 12 Months

Population: 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.

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).

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=301 Participants 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 n=157 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Number of Participants With Stroke-Free Success	229 Participants	105 Participants

Adverse Events

HeartWare® VAS

Serious events: 295 serious events

Other events: 95 other events

Deaths: 56 deaths

Control LVAD

Serious events: 152 serious events

Other events: 40 other events

Deaths: 31 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	HeartWare® VAS n=308 participants at risk 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.	Control LVAD n=157 participants at risk Implant of FDA-approved LVAD approved for destination therapy Control LVAD: Any FDA-approved LVAD for destination therapy.
Cardiac disorders Cardiac Arrhythmia	5.2% 16/308 • Number of events 19 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	4.5% 7/157 • Number of events 7 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Product Issues Device Malfunction/Failure	5.8% 18/308 • Number of events 26 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	0.64% 1/157 • Number of events 1 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Cardiac disorders Hypertension	5.2% 16/308 • Number of events 20 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	5.1% 8/157 • Number of events 9 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Infections and infestations Major Infection	10.7% 33/308 • Number of events 41 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	15.3% 24/157 • Number of events 32 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
General disorders Other Intermacs	9.4% 29/308 • Number of events 30 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	5.1% 8/157 • Number of events 8 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.

Additional Information

Thomas Vassiliades

Medtronic

Phone: +15085321942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	HeartWare® VAS n=308 participants at risk 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.	Control LVAD n=157 participants at risk Implant of FDA-approved LVAD approved for destination therapy Control LVAD: Any FDA-approved LVAD for destination therapy.
Blood and lymphatic system disorders Major Bleeding	50.6% 156/308 • Number of events 297 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	55.4% 87/157 • Number of events 190 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Cardiac disorders Cardiac Arrhythmia	30.8% 95/308 • Number of events 132 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	26.8% 42/157 • Number of events 49 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Product Issues Device Malfunction/Failure	19.5% 60/308 • Number of events 81 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	24.2% 38/157 • Number of events 46 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Blood and lymphatic system disorders Hemolysis	0.97% 3/308 • Number of events 4 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	5.1% 8/157 • Number of events 8 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Hepatobiliary disorders Hepatic Dysfunction	3.2% 10/308 • Number of events 10 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	3.8% 6/157 • Number of events 6 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Cardiac disorders Hypertension	8.8% 27/308 • Number of events 34 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	7.6% 12/157 • Number of events 12 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Infections and infestations Major Infection	48.7% 150/308 • Number of events 259 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	54.1% 85/157 • Number of events 149 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Cardiac disorders Myocardial Infarction	0.00% 0/308 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	1.3% 2/157 • Number of events 2 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Nervous system disorders Neurological Dysfunction	18.5% 57/308 • Number of events 83 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	15.3% 24/157 • Number of events 26 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Cardiac disorders Pericardial Fluid Collection	5.5% 17/308 • Number of events 18 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	8.3% 13/157 • Number of events 15 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Psychiatric disorders Psychiatric Episode	11.0% 34/308 • Number of events 35 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	7.0% 11/157 • Number of events 12 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Renal and urinary disorders Renal Dysfunction	10.4% 32/308 • Number of events 35 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	14.6% 23/157 • Number of events 25 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	19.8% 61/308 • Number of events 74 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	19.7% 31/157 • Number of events 37 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Cardiac disorders Right Heart Failure	30.5% 94/308 • Number of events 101 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	35.7% 56/157 • Number of events 61 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Vascular disorders Arterial Non-CNS Thromboembolism	0.97% 3/308 • Number of events 3 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	0.00% 0/157 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Vascular disorders Venous Thromboembolism	3.6% 11/308 • Number of events 11 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	2.5% 4/157 • Number of events 5 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
Skin and subcutaneous tissue disorders Wound Dehiscence	0.32% 1/308 • Number of events 1 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	0.64% 1/157 • Number of events 1 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.
General disorders Other Intermacs	71.1% 219/308 • Number of events 599 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.	67.5% 106/157 • Number of events 265 • 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. The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.