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

NCT00751972 | Completed Results DMC

• 1 other identifier: HW003
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 35

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

Outcome Measures

Primary Outcomes (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.

  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.

  180 days

Secondary Outcomes (6)

• Survival to 180 Days

  180 Days

• Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects

  180 Days

• Incidence of All Device Failures and Device Malfunctions

  180 Days

• Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Baseline and 180 Days

• Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days

  Baseline and 180 Days

Study Arms (1)

HeartWare® VAS

EXPERIMENTAL

Ventricular Assist Device (HeartWare® VAS)

Device: HeartWare® VAS

Interventions

HeartWare® VAS 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.

HeartWare® VAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (35)

Mayo Clinic (Arizona)

Phoenix, Arizona, 85054, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Gainesville

Gainesville, Florida, 32610, United States

Location

University of Miami / Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

IU Health Methodist

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Health

Indianapolis, Indiana, 46260, United States

Location

Jewish Hospital - Rudd Heart and Lung Institute

Louisville, Kentucky, 40202, United States

Location

John Ochsner Heart & Vascular Institute

New Orleans, Louisiana, 70115, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic / St. Marys Hospital

Rochester, Minnesota, 55902, United States

Location

Washington University / Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundatiojn

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (11)

• 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.

  PMID: 22619284 RESULT

• 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.

  PMID: 32740343 DERIVED

• 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.

  PMID: 32740129 DERIVED

• 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.

  PMID: 31030606 DERIVED

• 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.

  PMID: 26450000 DERIVED

• 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.

  PMID: 25813372 DERIVED

• 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.

  PMID: 25770405 DERIVED

• 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.

  PMID: 25200052 DERIVED

• 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.

  PMID: 25087103 DERIVED

• 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.

  PMID: 24418731 DERIVED

• 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.

  PMID: 23796152 DERIVED

Results Point of Contact

• Title: Director Clinical Project Management
• Organization: HeartWare Inc

sbell@heartwareinc.com

508 739-0867

Study Officials

• Mark Slaughter, MD

  Jewish Hospital/Univ of Louisville

  PRINCIPAL INVESTIGATOR

• Keith Aaronson, MD

  Univ of Michigan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 12, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2013
• Last Updated: May 30, 2018
• Results First Posted: May 2, 2014

Record last verified: 2018-05

Locations

US (35)