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

NCT ID: NCT00751972

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-08-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HeartWare® VAS

Ventricular Assist Device (HeartWare® VAS)

Group Type: EXPERIMENTAL

HeartWare® VAS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Slaughter, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish Hospital/Univ of Louisville

Keith Aaronson, MD

Role: PRINCIPAL_INVESTIGATOR

Univ of Michigan Medical Center

Locations

Mayo Clinic (Arizona)

Phoenix, Arizona, United States

Sharp Memorial Hospital

San Diego, California, United States

Stanford University School of Medicine

Stanford, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida Gainesville

Gainesville, Florida, United States

University of Miami / Jackson Memorial Hospital

Miami, Florida, United States

The Emory Clinic

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

IU Health Methodist

Indianapolis, Indiana, United States

St. Vincent Health

Indianapolis, Indiana, United States

Jewish Hospital - Rudd Heart and Lung Institute

Louisville, Kentucky, United States

John Ochsner Heart & Vascular Institute

New Orleans, Louisiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic / St. Marys Hospital

Rochester, Minnesota, United States

Washington University / Barnes Jewish Hospital

St Louis, Missouri, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic Foundatiojn

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Texas Heart Institute

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22619284 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32740343 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 31030606 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26450000 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25813372 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25770405 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25200052 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 24418731 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23796152 (View on PubMed)

Other Identifiers

HW003

Identifier Type: -

Identifier Source: org_study_id