Trial Outcomes & Findings for Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure (NCT NCT00751972)

NCT ID: NCT00751972

Last Updated: 2018-05-30

Results Overview

The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.

Recruitment status

COMPLETED

Study phase

Target enrollment

140 participants

Primary outcome timeframe

180 days

Results posted on

2018-05-30

Participant Flow

A total of 140 patients were enrolled at 30 sites into the study by giving written informed consent and were implanted with a HeartWare HVAD between August 18 2008 and February 23 2010.

This was a non randomized,open label,contemporaneously controlled trial. Pats. in the treatment arm were screened against the incl. \& excl. criteria to determine eligibility to proceed to implant of the investigational device. Control Pats.contemporaneously entered into the INTERMACS (NCT00119834) database were selected using specified criteria.

Participant milestones

Participant milestones
Measure	HeartWare® VAS Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Overall Study STARTED	140	499
Overall Study COMPLETED	140	499
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeartWare® VAS n=140 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control n=499 Participants Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS (NCT00119834) during the same enrollment period.	Total n=639 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 10.3 • n=5 Participants	52.2 years STANDARD_DEVIATION 12.2 • n=7 Participants	52.2 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	120 Participants n=7 Participants	159 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	379 Participants n=7 Participants	480 Participants n=5 Participants
Region of Enrollment United States	140 participants n=5 Participants	499 participants n=7 Participants	639 participants n=5 Participants
Body Surface Area (BSA)	2.06 m^2 STANDARD_DEVIATION 0.28 • n=5 Participants	2.07 m^2 STANDARD_DEVIATION 0.3 • n=7 Participants	2.07 m^2 STANDARD_DEVIATION 0.29 • n=5 Participants
Blood Urea Nitrogen (BUN)	9.12 mmol/L STANDARD_DEVIATION 4.92 • n=5 Participants	10.32 mmol/L STANDARD_DEVIATION 7.48 • n=7 Participants	10.06 mmol/L STANDARD_DEVIATION 7.01 • n=5 Participants
Right Atrial Pressure (RAP)	11.14 mmHg STANDARD_DEVIATION 7.18 • n=5 Participants	11.91 mmHg STANDARD_DEVIATION 6.79 • n=7 Participants	11.84 mmHg STANDARD_DEVIATION 6.82 • n=5 Participants
Serum creatinine	114.1 µmol/L STANDARD_DEVIATION 39.1 • n=5 Participants	121.9 µmol/L STANDARD_DEVIATION 50 • n=7 Participants	120.2 µmol/L STANDARD_DEVIATION 47.9 • n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: The primary effectiveness analyses was performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=140 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control n=497 Participants Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.	90.7 Percentage of participants with success	90.1 Percentage of participants with success

SECONDARY outcome

Timeframe: 180 Days

Population: The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).

All subjects will be followed for date of death until 180 days.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=140 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control n=499 Participants Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Survival to 180 Days	94.3 Percentage of participants with survival	91.2 Percentage of participants with survival

SECONDARY outcome

Timeframe: 180 Days

Population: The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).

Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=140 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Bleeding requiring reoperation	17.1 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Infections - Local	25.0 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Infections - Driveline	12.1 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Infections - Sepsis	11.4 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Neurologic Event-Ischemic Cerebrovascular accident	7.1 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Neurologic Event-Hemorrhagic CVA	4.3 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Neurologic Event - Transient Ischemic Attack(TIA)A	4.3 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Right Heart Failure - requiring Inotropes	16.0 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Right Heart Failure - requiring RVAD	2.9 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Respiratory Dysfunction	19.3 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Arterial Thromboembolism	2.9 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Venous Thromboembolism	6.4 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Renal Dysfunction	5.7 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Hepatic Dysfunction	2.9 percentage of patients	—
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects Hemolysis	3.6 percentage of patients	—

SECONDARY outcome

Timeframe: 180 Days

Population: The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).

The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=140 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Incidence of All Device Failures and Device Malfunctions Pump Failure (exchange)	7 Number of events	—
Incidence of All Device Failures and Device Malfunctions Non pump failure	19 Number of events	—

SECONDARY outcome

Timeframe: Baseline and 180 Days

Population: Number of participants with both baseline and 180 day data were used for this analysis of QOL.

KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes. The KCCQ's questions are used to calculate scores in ten domains: Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=70 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	30.94 units on a KCCQ scale Standard Deviation 26.51	—

SECONDARY outcome

Timeframe: Baseline and 180 Days

Population: Number of participants with both baseline and 180 day data were used for this analysis of 6 minute walk distance.

The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue. A longer distance walked is indicative of a better outcome.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=74 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days	150.14 meters Standard Deviation 214.13	—

SECONDARY outcome

Timeframe: Baseline and 180 Days

Population: Number of participants with both baseline and 180 day data were used for this analysis of QOL

The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome. The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=72 Participants Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Contemporaneous Control Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D	29.53 units on a EuroQol EQ-5D scale Standard Deviation 25.18	—

Adverse Events

HeartWare® VAS

Serious events: 118 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HeartWare® VAS n=140 participants at risk Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
Cardiac disorders Cardiac disorders	49.3% 69/140 • Number of events 99 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Respiratory, thoracic and mediastinal disorders "Respiratory, thoracic and mediastinal disorders"	33.6% 47/140 • Number of events 78 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Infections and infestations Infections and infestations	26.4% 37/140 • Number of events 56 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Injury, poisoning and procedural complications "Injury, poisoning and procedural complications"	17.9% 25/140 • Number of events 34 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Nervous system disorders Nervous system disorders	16.4% 23/140 • Number of events 32 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Gastrointestinal disorders Gastrointestinal disorders	12.9% 18/140 • Number of events 29 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Vascular disorders Vascular disorders	14.3% 20/140 • Number of events 26 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Investigations Investigations	12.1% 17/140 • Number of events 21 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Blood and lymphatic system disorders Blood and lymphatic system disorders	8.6% 12/140 • Number of events 17 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Renal and urinary disorders Renal and urinary disorders	10.0% 14/140 • Number of events 17 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
General disorders General disorders and administration site conditions	7.9% 11/140 • Number of events 12 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Metabolism and nutrition disorders Metabolism and nutrition disorders	6.4% 9/140 • Number of events 11 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Psychiatric disorders Psychiatric disorders	3.6% 5/140 • Number of events 5 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Eye disorders Eye disorders	2.1% 3/140 • Number of events 3 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	2.1% 3/140 • Number of events 3 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Reproductive system and breast disorders Reproductive system and breast disorders	2.1% 3/140 • Number of events 3 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Hepatobiliary disorders Hepatobiliary disorders	1.4% 2/140 • Number of events 2 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Ear and labyrinth disorders Ear and labyrinth disorders	0.71% 1/140 • Number of events 1 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Immune system disorders Immune system disorders	0.71% 1/140 • Number of events 1 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) "Neoplasms benign, malignant and unspecified (including cysts and polyps)"	0.71% 1/140 • Number of events 1 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Social circumstances Social circumstances	0.71% 1/140 • Number of events 1 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.

Other adverse events

Other adverse events
Measure	HeartWare® VAS n=140 participants at risk Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
Respiratory, thoracic and mediastinal disorders "Respiratory, thoracic and mediastinal disorders"	32.9% 46/140 • Number of events 66 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Cardiac disorders Cardiac disorders	26.4% 37/140 • Number of events 49 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Nervous system disorders Nervous system disorders	22.9% 32/140 • Number of events 45 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Investigations Investigations	15.7% 22/140 • Number of events 37 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Metabolism and nutrition disorders Metabolism and nutrition disorders	13.6% 19/140 • Number of events 23 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Gastrointestinal disorders Gastrointestinal disorders	11.4% 16/140 • Number of events 20 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Injury, poisoning and procedural complications "Injury, poisoning and procedural complications"	11.4% 16/140 • Number of events 17 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
General disorders General disorders and administration site conditions	8.6% 12/140 • Number of events 16 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Blood and lymphatic system disorders Blood and lymphatic system disorders	5.7% 8/140 • Number of events 11 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Vascular disorders Vascular disorders	7.1% 10/140 • Number of events 11 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	6.4% 9/140 • Number of events 9 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.
Infections and infestations Infections and infestations	5.0% 7/140 • Number of events 7 • Adverse events were collected and are reported during the 180 day primary endpoint period. Treatment emergent adverse events are defined as events occurring after the skin incision for implantation of the pump. Adverse events that resulted in death, those assessed by the principal investigator as an SAE, any UADE, or those that met the definition of an INTERMACS event, were sent to the Clinical Events Committee with associated data.The Clinical Events Committee evaluated whether the event met the appropriate definition and determined the event's relationship to the device.

Additional Information

Director Clinical Project Management

HeartWare Inc

Phone: 508 739-0867

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60