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

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00751972
• Collaborator: (none)
• Enrollment: 140
• Locations: 35
• Arm: 1
• Duration (Months): 60
• Patients Per Site: 4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival 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. Secondary endpoints include:

• Overall survival

• Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects.

• Incidence of all device failures and device malfunctions

• Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D

• Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk

The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Device: HeartWare® VAS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HeartWare® VAS Ventricular Assist Device (HeartWare® VAS)	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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. [180 days]

   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.

Secondary Outcome Measures

1. Survival to 180 Days [180 Days]

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

2. Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects [180 Days]

   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.

3. Incidence of All Device Failures and Device Malfunctions [180 Days]

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

4. Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [Baseline and 180 Days]

   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.

5. Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days [Baseline and 180 Days]

   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.

6. Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D [Baseline and 180 Days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Must be at least 18 years of age at enrollment.

2. Body Surface Area (BSA) greater than or equal to 1.2 m2.

3. Patient is NYHA Class IV

4. Patient listed for cardiac transplantation

5. Patient meets United Network for Organ Sharing (UNOS) Status 1A or 1B listing criteria.

6. HeartWare® LVAD implant is planned as a bridge to transplant

7. The patient or legally authorized representative has signed the informed consent form

Exclusion Criteria:

1. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)

2. Prior cardiac transplant.

3. History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm.

4. Cardiothoracic surgery within 30 days of enrollment.

5. Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described (Figure 2) in the guidelines published in ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction; A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. JACC Vol. 50, No.7, 2007.

6. On ventilator support for > 72 hours within the fours days immediately prior to enrollment.

7. Pulmonary embolus within three weeks of enrollment as documented by computed tomography (CT) scan or nuclear scan.

8. Symptomatic cerebrovascular disease or a > 80% carotid stenosis.

9. Patients have moderate to severe aortic insufficiency without plans for correction during pump implantation surgery.

10. Patients with mechanical, animal or human tissue heart valves are excluded.

11. Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO)at the time of HeartWare® LVAD screening/enrollment or right atrial pressure > 20 mmHg on multiple inotropes, right ventricular ejection fraction (RVEF) <15% or clinical signs including lower extremity edema, ascites or pleural effusions refractory to treatment with diuretics and two inotropic drugs.

12. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.

13. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 100,000, INR > 1.6 or PTT > 2.5 times control in the absence of anticoagulation therapy).

14. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.

15. Serum creatinine greater than 3.0 times the upper limit of normal within 48 hours of study enrollment or requiring dialysis (does not include use of ultra-filtration for fluid removal).

16. All three listed liver enzymes [AST (SGOT), ALT (SGPT), or LDH] > 3 times upper limit of normal or a total bilirubin > 3 mg/dl within 24 hours of study enrollment, or biopsy proven liver cirrhosis or portal hypertension.

17. Pulmonary vascular resistance is unresponsive (fixed) to pharmacologic manipulation as demonstrated by a pulmonary artery systolic pressure exceeding 60mmHg in conjunction with any one of the three following variables:

• Pulmonary vascular resistance is greater than 5 Woods Units or

• Pulmonary vascular resistance index is greater than 6 Woods Units or

• Transpulmonary gradient exceeds 16 to 20 mmHg

1. Patients requiring aortic, mitral, tricuspid or pulmonary valve replacements (including bioprosthetic valves) or left ventricular (LV) aneurysm resections.

2. Participation in any other study involving investigational drugs or devices.

3. Severe illness, other than heart disease, which would exclude cardiac transplantation.

4. Pregnancy.

5. Patient unwilling or unable to comply with study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic (Arizona)	Phoenix	Arizona	United States	85054
2	Sharp Memorial Hospital	San Diego	California	United States	92123
3	Stanford University School of Medicine	Stanford	California	United States	94305
4	Washington Hospital Center	Washington	District of Columbia	United States	20010
5	University of Florida Gainesville	Gainesville	Florida	United States	32610
6	University of Miami / Jackson Memorial Hospital	Miami	Florida	United States	33136
7	The Emory Clinic	Atlanta	Georgia	United States	30322
8	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
9	University of Chicago	Chicago	Illinois	United States	60637
10	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
11	IU Health Methodist	Indianapolis	Indiana	United States	46202
12	St. Vincent Health	Indianapolis	Indiana	United States	46260
13	Jewish Hospital - Rudd Heart and Lung Institute	Louisville	Kentucky	United States	40202
14	John Ochsner Heart & Vascular Institute	New Orleans	Louisiana	United States	70115
15	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
16	Tufts Medical Center	Boston	Massachusetts	United States	02111
17	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109
18	Henry Ford Hospital	Detroit	Michigan	United States	48202
19	University of Minnesota	Minneapolis	Minnesota	United States	55455
20	Mayo Clinic / St. Marys Hospital	Rochester	Minnesota	United States	55902
21	Washington University / Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
22	Montefiore Medical Center	Bronx	New York	United States	10467
23	Duke University Medical Center	Durham	North Carolina	United States	27710
24	Cleveland Clinic Foundatiojn	Cleveland	Ohio	United States	44195
25	Ohio State University Medical Center	Columbus	Ohio	United States	43210
26	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
27	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
28	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
29	UT Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390
30	Texas Heart Institute	Houston	Texas	United States	77030
31	The Methodist Hospital	Houston	Texas	United States	77030
32	Intermountain Medical Center	Murray	Utah	United States	84107
33	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
34	Providence Sacred Heart Medical Center	Spokane	Washington	United States	99204
35	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Mark Slaughter, MD, Jewish Hospital/Univ of Louisville
• Principal Investigator: Keith Aaronson, MD, Univ of Michigan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00751972
• Other Study ID Numbers: HW003
• First Posted: Sep 12, 2008
• Last Update Posted: May 30, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	HeartWare® VAS	Contemporaneous Control	Total
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS (NCT00119834) during the same enrollment period.	Total of all reporting groups
Overall Participants	140	499	639
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.3 (10.3)	52.2 (12.2)	52.2 (13.1)
Sex: Female, Male (Count of Participants)
Female	39 27.9%	120 24%	159 24.9%
Male	101 72.1%	379 76%	480 75.1%
Region of Enrollment (participants) [Number]
United States	140 100%	499 100%	639 100%
Body Surface Area (BSA) (m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m^2]	2.06 (0.28)	2.07 (0.3)	2.07 (0.29)
Blood Urea Nitrogen (BUN) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	9.12 (4.92)	10.32 (7.48)	10.06 (7.01)
Right Atrial Pressure (RAP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	11.14 (7.18)	11.91 (6.79)	11.84 (6.82)
Serum creatinine (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	114.1 (39.1)	121.9 (50)	120.2 (47.9)

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HeartWare® VAS	Contemporaneous Control
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Measure Participants	140	497
Number [Percentage of participants with success]	90.7 64.8%	90.1 18.1%

2. Secondary Outcome

Title	Survival to 180 Days
Description	All subjects will be followed for date of death until 180 days.
Time Frame	180 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HeartWare® VAS	Contemporaneous Control
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)	Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
Measure Participants	140	499
Number [Percentage of participants with survival]	94.3 67.4%	91.2 18.3%

3. Secondary Outcome

Title	Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects
Description	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.
Time Frame	180 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HeartWare® VAS
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
Measure Participants	140
Bleeding requiring reoperation	17.1
Infections - Local	25.0
Infections - Driveline	12.1
Infections - Sepsis	11.4
Neurologic Event-Ischemic Cerebrovascular accident	7.1
Neurologic Event-Hemorrhagic CVA	4.3
Neurologic Event - Transient Ischemic Attack(TIA)A	4.3
Right Heart Failure - requiring Inotropes	16.0
Right Heart Failure - requiring RVAD	2.9
Respiratory Dysfunction	19.3
Arterial Thromboembolism	2.9
Venous Thromboembolism	6.4
Renal Dysfunction	5.7
Hepatic Dysfunction	2.9
Hemolysis	3.6

4. Secondary Outcome

Title	Incidence of All Device Failures and Device Malfunctions
Description	The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.
Time Frame	180 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HeartWare® VAS
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
Measure Participants	140
Pump Failure (exchange)	7
Non pump failure	19

5. Secondary Outcome

Title	Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description	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.
Time Frame	Baseline and 180 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HeartWare® VAS
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
Measure Participants	70
Mean (Standard Deviation) [units on a KCCQ scale]	30.94 (26.51)

6. Secondary Outcome

Title	Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days
Description	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.
Time Frame	Baseline and 180 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HeartWare® VAS
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
Measure Participants	74
Mean (Standard Deviation) [meters]	150.14 (214.13)

7. Secondary Outcome

Title	Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D
Description	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.
Time Frame	Baseline and 180 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HeartWare® VAS
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
Measure Participants	72
Mean (Standard Deviation) [units on a EuroQol EQ-5D scale]	29.53 (25.18)

Adverse Events

Time Frame	Adverse events were collected and are reported during the 180 day primary endpoint period.
Adverse Event Reporting Description	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.
Arm/Group Title	HeartWare® VAS
Arm/Group Description	Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
All Cause Mortality
	HeartWare® VAS
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	HeartWare® VAS
	Affected / at Risk (%)	# Events
Total	118/140 (84.3%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	12/140 (8.6%)	17
Cardiac disorders
Cardiac disorders	69/140 (49.3%)	99
Ear and labyrinth disorders
Ear and labyrinth disorders	1/140 (0.7%)	1
Eye disorders
Eye disorders	3/140 (2.1%)	3
Gastrointestinal disorders
Gastrointestinal disorders	18/140 (12.9%)	29
General disorders
General disorders and administration site conditions	11/140 (7.9%)	12
Hepatobiliary disorders
Hepatobiliary disorders	2/140 (1.4%)	2
Immune system disorders
Immune system disorders	1/140 (0.7%)	1
Infections and infestations
Infections and infestations	37/140 (26.4%)	56
Injury, poisoning and procedural complications
"Injury, poisoning and procedural complications"	25/140 (17.9%)	34
Investigations
Investigations	17/140 (12.1%)	21
Metabolism and nutrition disorders
Metabolism and nutrition disorders	9/140 (6.4%)	11
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	3/140 (2.1%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
"Neoplasms benign, malignant and unspecified (including cysts and polyps)"	1/140 (0.7%)	1
Nervous system disorders
Nervous system disorders	23/140 (16.4%)	32
Psychiatric disorders
Psychiatric disorders	5/140 (3.6%)	5
Renal and urinary disorders
Renal and urinary disorders	14/140 (10%)	17
Reproductive system and breast disorders
Reproductive system and breast disorders	3/140 (2.1%)	3
Respiratory, thoracic and mediastinal disorders
"Respiratory, thoracic and mediastinal disorders"	47/140 (33.6%)	78
Social circumstances
Social circumstances	1/140 (0.7%)	1
Vascular disorders
Vascular disorders	20/140 (14.3%)	26
Other (Not Including Serious) Adverse Events
	HeartWare® VAS
	Affected / at Risk (%)	# Events
Total	105/140 (75%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	8/140 (5.7%)	11
Cardiac disorders
Cardiac disorders	37/140 (26.4%)	49
Gastrointestinal disorders
Gastrointestinal disorders	16/140 (11.4%)	20
General disorders
General disorders and administration site conditions	12/140 (8.6%)	16
Infections and infestations
Infections and infestations	7/140 (5%)	7
Injury, poisoning and procedural complications
"Injury, poisoning and procedural complications"	16/140 (11.4%)	17
Investigations
Investigations	22/140 (15.7%)	37
Metabolism and nutrition disorders
Metabolism and nutrition disorders	19/140 (13.6%)	23
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	9/140 (6.4%)	9
Nervous system disorders
Nervous system disorders	32/140 (22.9%)	45
Respiratory, thoracic and mediastinal disorders
"Respiratory, thoracic and mediastinal disorders"	46/140 (32.9%)	66
Vascular disorders
Vascular disorders	10/140 (7.1%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.