Trial Outcomes & Findings for Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials (NCT NCT01832610)

Last Updated: 2019-07-11

Results Overview

Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

Implant to 5 years

Results posted on

2019-07-11

Participant Flow

Of the 101 enrolled subjects, 17 subjects enrolled post-transplant and were no longer on the HVAD device at the time of enrollment, leaving 84 subjects who enrolled while still on the HVAD device.

Participant milestones

Participant milestones
Measure	HeartWare® VAS Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Overall Study STARTED	101
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeartWare® VAS n=101 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Age, Continuous	54.4 years STANDARD_DEVIATION 12.62 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	37 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White	59 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants
Enrollment Characteristics On Device	84 Participants n=5 Participants
Enrollment Characteristics Post Transplant	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Implant to 5 years

Population: All enrolled subjects are included

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=101 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Overall Survival on Device	52.9 Percent Probability of Survival

SECONDARY outcome

Timeframe: Implant to 5 years

Population: All enrolled subjects are included.

The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=101 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Final Patient Status Alive on Original Device	21 Participants
Final Patient Status Alive Post Exchange	5 Participants
Final Patient Status Alive Post Explant for Transplant	41 Participants
Final Patient Status Alive Post Explant for Recovery	0 Participants
Final Patient Status Dead on Original Device	22 Participants
Final Patient Status Dead Post Exchange	6 Participants
Final Patient Status Dead Post Explant for Transplant	6 Participants
Final Patient Status Dead Post Explant for Recovery	0 Participants

SECONDARY outcome

Timeframe: Enrollment into HW-PAS-03 to 5 years

Population: Participants who enrolled into the trial on device are included.

A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=84 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Re-hospitalizations	3.9 Re-hospitalizations Standard Deviation 3.80

SECONDARY outcome

Timeframe: Enrollment into HW-PAS-03 to 5 years

Population: Participants who enrolled into the trial on device are included.

Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=84 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Number of Participants Experiencing Any Adverse Event Per Intermacs Definition	66 Participants

SECONDARY outcome

Timeframe: Change from baseline to 5 years

Population: Participants who enrolled into the trial on device are included. Participants also had to reach the Month 60 visit and complete both the baseline and Month 60 assessments to be analyzed.

Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=15 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	20.1 score on a scale Standard Deviation 21.32

SECONDARY outcome

Timeframe: Enrollment to 5 years

Population: Participants who enrolled into the trial on device are included. Participants also had to reach the Month 60 visit complete the assessment to be analyzed.

The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=19 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Health Status Change Measured by EuroQol EQ-5D (Version 5L)	66.84 score on a scale Standard Deviation 22.124

SECONDARY outcome

Timeframe: Change from baseline to 5 years

Population: Participants who enrolled into the trial on device were included. Participants also had to reach the Month 60 visit and complete the assessment to be analyzed.

Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=22 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Change in Functional Status Measured by New York Heart Association (NYHA) Class No Change in NYHA Class	2 Participants
Change in Functional Status Measured by New York Heart Association (NYHA) Class Improved 1 NYHA Class	5 Participants
Change in Functional Status Measured by New York Heart Association (NYHA) Class Improved 2 NYHA Classes	7 Participants
Change in Functional Status Measured by New York Heart Association (NYHA) Class Improved 3 NYHA Classes	8 Participants

SECONDARY outcome

Timeframe: Change from baseline to 5 years

Population: Participants who enrolled into the trial on device are included. Subjects also had to reach the Month 60 visit and complete the assessment or indicate Not Completed to be analyzed at both the baseline and Month 60 visits. If the subject did not complete the assessment, a value of 0 was imputed.

Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=22 Participants Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Change in Functional Status Measured by 6-minute Walk	106.6 Meters Standard Deviation 184.05

Adverse Events

HeartWare® VAS

Serious events: 62 serious events

Other events: 10 other events

Deaths: 34 deaths

Serious adverse events

Serious adverse events
Measure	HeartWare® VAS n=84 participants at risk Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Blood and lymphatic system disorders Major Bleeding	22.6% 19/84 • Number of events 35 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Cardiac disorders Cardiac Arrhythmia	14.3% 12/84 • Number of events 15 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Product Issues Device Malfunction	34.5% 29/84 • Number of events 34 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Blood and lymphatic system disorders Hemolysis	1.2% 1/84 • Number of events 1 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Hepatobiliary disorders Hepatic Dysfunction	2.4% 2/84 • Number of events 3 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Cardiac disorders Hypertension	1.2% 1/84 • Number of events 3 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Infections and infestations Major Infection	44.0% 37/84 • Number of events 69 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Cardiac disorders Myocardial Infarction	1.2% 1/84 • Number of events 1 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Nervous system disorders Neurological Dysfunction	16.7% 14/84 • Number of events 19 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Cardiac disorders Pericardial Fluid Collection	0.00% 0/84 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Psychiatric disorders Psychiatric Episode	6.0% 5/84 • Number of events 5 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Renal and urinary disorders Renal Dysfunction	8.3% 7/84 • Number of events 7 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	13.1% 11/84 • Number of events 11 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Cardiac disorders Right Heart Failure	3.6% 3/84 • Number of events 3 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Vascular disorders Arterial Non-CNS Thromboembolism	1.2% 1/84 • Number of events 1 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Vascular disorders Venous Thromboembolism	3.6% 3/84 • Number of events 3 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Skin and subcutaneous tissue disorders Wound Dehiscence	0.00% 0/84 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
General disorders Other Intermacs	57.1% 48/84 • Number of events 161 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.

Other adverse events

Other adverse events
Measure	HeartWare® VAS n=84 participants at risk Ventricular Assist Device (HeartWare® VAS) HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Product Issues Device Malfunction	6.0% 5/84 • Number of events 5 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.
Infections and infestations Major Infection	6.0% 5/84 • Number of events 6 • The adverse events are summarized from the date of enrollment through 5 years while on the originally implanted device. Only participants who enrolled into the trial on device are included. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device. Subjects who enrolled into the trial post-transplant (off device) (N=17) did not have any adverse events collected during the trial.

Additional Information

Thomas Vassiliades, MD - VP MCS Clinical/Medical Affairs

Medtronic

Phone: +15085321956

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