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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HeartWare® VAS
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  18. Patients requiring aortic, mitral, tricuspid or pulmonary valve replacements (including bioprosthetic valves) or left ventricular (LV) aneurysm resections.
  19. Participation in any other study involving investigational drugs or devices.
  20. Severe illness, other than heart disease, which would exclude cardiac transplantation.
  21. Pregnancy.
  22. Patient unwilling or unable to comply with study requirements.

Sites / Locations

  • Mayo Clinic (Arizona)
  • Sharp Memorial Hospital
  • Stanford University School of Medicine
  • Washington Hospital Center
  • University of Florida Gainesville
  • University of Miami / Jackson Memorial Hospital
  • The Emory Clinic
  • Northwestern Memorial Hospital
  • University of Chicago
  • Advocate Christ Medical Center
  • IU Health Methodist
  • St. Vincent Health
  • Jewish Hospital - Rudd Heart and Lung Institute
  • John Ochsner Heart & Vascular Institute
  • Johns Hopkins Hospital
  • Tufts Medical Center
  • University of Michigan Hospital
  • Henry Ford Hospital
  • University of Minnesota
  • Mayo Clinic / St. Marys Hospital
  • Washington University / Barnes Jewish Hospital
  • Montefiore Medical Center
  • Duke University Medical Center
  • Cleveland Clinic Foundatiojn
  • Ohio State University Medical Center
  • Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • UT Southwestern Medical Center at Dallas
  • Texas Heart Institute
  • The Methodist Hospital
  • Intermountain Medical Center
  • Inova Fairfax Hospital
  • Providence Sacred Heart Medical Center
  • Aurora St. Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HeartWare® VAS

Arm Description

Ventricular Assist Device (HeartWare® VAS)

Outcomes

Primary Outcome Measures

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.
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

Survival to 180 Days
All subjects will be followed for date of death until 180 days.
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects
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.
Incidence of All Device Failures and Device Malfunctions
The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.
Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Change in Distance Walked in the 6-minute Walk Test Between 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.
Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D
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.

Full Information

First Posted
September 10, 2008
Last Updated
May 24, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00751972
Brief Title
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
Acronym
ADVANCE
Official Title
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HeartWare® VAS
Arm Type
Experimental
Arm Description
Ventricular Assist Device (HeartWare® VAS)
Intervention Type
Device
Intervention Name(s)
HeartWare® VAS
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Survival to 180 Days
Description
All subjects will be followed for date of death until 180 days.
Time Frame
180 Days
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be at least 18 years of age at enrollment. Body Surface Area (BSA) greater than or equal to 1.2 m2. Patient is NYHA Class IV Patient listed for cardiac transplantation Patient meets United Network for Organ Sharing (UNOS) Status 1A or 1B listing criteria. HeartWare® LVAD implant is planned as a bridge to transplant The patient or legally authorized representative has signed the informed consent form Exclusion Criteria: Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) Prior cardiac transplant. History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm. Cardiothoracic surgery within 30 days of enrollment. 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. On ventilator support for > 72 hours within the fours days immediately prior to enrollment. Pulmonary embolus within three weeks of enrollment as documented by computed tomography (CT) scan or nuclear scan. Symptomatic cerebrovascular disease or a > 80% carotid stenosis. Patients have moderate to severe aortic insufficiency without plans for correction during pump implantation surgery. Patients with mechanical, animal or human tissue heart valves are excluded. 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. 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. 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). 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. 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). 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. 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 Patients requiring aortic, mitral, tricuspid or pulmonary valve replacements (including bioprosthetic valves) or left ventricular (LV) aneurysm resections. Participation in any other study involving investigational drugs or devices. Severe illness, other than heart disease, which would exclude cardiac transplantation. Pregnancy. Patient unwilling or unable to comply with study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Slaughter, MD
Organizational Affiliation
Jewish Hospital/Univ of Louisville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith Aaronson, MD
Organizational Affiliation
Univ of Michigan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic (Arizona)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami / Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
IU Health Methodist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Jewish Hospital - Rudd Heart and Lung Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
John Ochsner Heart & Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic / St. Marys Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Washington University / Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundatiojn
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22619284
Citation
Aaronson KD, Slaughter MS, Miller LW, McGee EC, Cotts WG, Acker MA, Jessup ML, Gregoric ID, Loyalka P, Frazier OH, Jeevanandam V, Anderson AS, Kormos RL, Teuteberg JJ, Levy WC, Naftel DC, Bittman RM, Pagani FD, Hathaway DR, Boyce SW; HeartWare Ventricular Assist Device (HVAD) Bridge to Transplant ADVANCE Trial Investigators. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation. 2012 Jun 26;125(25):3191-200. doi: 10.1161/CIRCULATIONAHA.111.058412. Epub 2012 May 22.
Results Reference
result
PubMed Identifier
32740343
Citation
Mahr C, McGee E Jr, Cheung A, Mokadam NA, Strueber M, Slaughter MS, Danter MR, Levy WC, Cheng RK, Beckman JA, May DM, Ismyrloglou E, Tsintzos SI, Silvestry SC. Cost-Effectiveness of Thoracotomy Approach for the Implantation of a Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):855-861. doi: 10.1097/MAT.0000000000001209. Erratum In: ASAIO J. 2021 Aug 1;67(8):e148.
Results Reference
derived
PubMed Identifier
32740129
Citation
Silvestry SC, Mahr C, Slaughter MS, Levy WC, Cheng RK, May DM, Ismyrloglou E, Tsintzos SI, Tuttle E, Cook K, Birk E, Gomes A, Graham S, Cotts WG. Cost-Effectiveness of a Small Intrapericardial Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):862-870. doi: 10.1097/MAT.0000000000001211. Erratum In: ASAIO J. 2021 Aug 1;67(8):e149.
Results Reference
derived
PubMed Identifier
31030606
Citation
Rahman F, McEvoy JW, Ohkuma T, Marre M, Hamet P, Harrap S, Mancia G, Rodgers A, Selvin E, Williams B, Muntner P, Chalmers J, Woodward M. Effects of Blood Pressure Lowering on Clinical Outcomes According to Baseline Blood Pressure and Cardiovascular Risk in Patients With Type 2 Diabetes Mellitus. Hypertension. 2019 Jun;73(6):1291-1299. doi: 10.1161/HYPERTENSIONAHA.118.12414.
Results Reference
derived
PubMed Identifier
26450000
Citation
Teuteberg JJ, Slaughter MS, Rogers JG, McGee EC, Pagani FD, Gordon R, Rame E, Acker M, Kormos RL, Salerno C, Schleeter TP, Goldstein DJ, Shin J, Starling RC, Wozniak T, Malik AS, Silvestry S, Ewald GA, Jorde UP, Naka Y, Birks E, Najarian KB, Hathaway DR, Aaronson KD; ADVANCE Trial Investigators. The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies. JACC Heart Fail. 2015 Oct;3(10):818-28. doi: 10.1016/j.jchf.2015.05.011.
Results Reference
derived
PubMed Identifier
25813372
Citation
Birks EJ, McGee EC Jr, Aaronson KD, Boyce S, Cotts WG, Najjar SS, Pagani FD, Hathaway DR, Najarian K, Jacoski MV, Slaughter MS; ADVANCE Trial Investigators. An examination of survival by sex and race in the HeartWare Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) and continued access protocol trials. J Heart Lung Transplant. 2015 Jun;34(6):815-24. doi: 10.1016/j.healun.2014.12.011. Epub 2014 Dec 29.
Results Reference
derived
PubMed Identifier
25770405
Citation
Goldstein DJ, Aaronson KD, Tatooles AJ, Silvestry SC, Jeevanandam V, Gordon R, Hathaway DR, Najarian KB, Slaughter MS; ADVANCE Investigators. Gastrointestinal bleeding in recipients of the HeartWare Ventricular Assist System. JACC Heart Fail. 2015 Apr;3(4):303-13. doi: 10.1016/j.jchf.2014.11.008. Epub 2015 Mar 11.
Results Reference
derived
PubMed Identifier
25200052
Citation
Milano C, Pagani FD, Slaughter MS, Pham DT, Hathaway DR, Jacoski MV, Najarian KB, Aaronson KD; ADVANCE Investigators. Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures. Circulation. 2014 Sep 9;130(11 Suppl 1):S3-11. doi: 10.1161/CIRCULATIONAHA.113.007911.
Results Reference
derived
PubMed Identifier
25087103
Citation
John R, Aaronson KD, Pae WE, Acker MA, Hathaway DR, Najarian KB, Slaughter MS; HeartWare Bridge to Transplant ADVANCE Trial Investigators. Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device. J Heart Lung Transplant. 2014 Oct;33(10):1066-73. doi: 10.1016/j.healun.2014.05.010. Epub 2014 Jun 4.
Results Reference
derived
PubMed Identifier
24418731
Citation
Najjar SS, Slaughter MS, Pagani FD, Starling RC, McGee EC, Eckman P, Tatooles AJ, Moazami N, Kormos RL, Hathaway DR, Najarian KB, Bhat G, Aaronson KD, Boyce SW; HVAD Bridge to Transplant ADVANCE Trial Investigators. An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2014 Jan;33(1):23-34. doi: 10.1016/j.healun.2013.12.001. Epub 2013 Dec 12.
Results Reference
derived
PubMed Identifier
23796152
Citation
Slaughter MS, Pagani FD, McGee EC, Birks EJ, Cotts WG, Gregoric I, Howard Frazier O, Icenogle T, Najjar SS, Boyce SW, Acker MA, John R, Hathaway DR, Najarian KB, Aaronson KD; HeartWare Bridge to Transplant ADVANCE Trial Investigators. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2013 Jul;32(7):675-83. doi: 10.1016/j.healun.2013.04.004.
Results Reference
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Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure

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