A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by HeartWare, Inc.
Information provided by (Responsible Party):
HeartWare, Inc.
ClinicalTrials.gov Identifier:
First received: October 17, 2013
Last updated: May 28, 2015
Last verified: May 2015

This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 5 years post implant.

Condition Intervention
Chronic Heart Failure
Device: HeartWare® VAS
Device: Control LVAD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

Resource links provided by NLM:

Further study details as provided by HeartWare, Inc.:

Primary Outcome Measures:
  • The primary endpoint is the incidence at 12 months on the originally implanted device of neurologic injury, defined as an ICVA or HCVA with MRS > 0 at 24-weeks post-stroke, or a TIA, or a spinal cord infarction. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stroke-free success [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    There are two secondary endpoints: 1. first secondary endpoint is the reduction in stroke/TIA incidence at 12 months on the originally implanted HVAD compared to 17.7% (the lower bound of a pre-defined margin of superiority) in a new cohort of subjects receiving optimal blood pressure management; 2. the second secondary endpoint is a non-inferiority test comparing HVAD to control LVAD considering stroke-free success (Modified Rankin Score <4 at 24-weeks post-stroke) at 12 months .

Estimated Enrollment: 465
Study Start Date: October 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HeartWare® VAS
Implant of HeartWare® Ventricular Assist System
Device: HeartWare® VAS
The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Active Comparator: Control LVAD
Implant of FDA-approved LVAD approved for destination therapy
Device: Control LVAD
Any FDA-approved LVAD for destination therapy.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Must be ≥18 years of age at consent
  2. Body Surface Area (BSA) ≥ 1.2 m2
  3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following)a. On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or b. In Class III or Class IV heart failure for at least 14 days, and dependent on intra-aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days
  4. Left ventricular ejection fraction ≤ 25%
  5. LVAD implant is intended as destination therapy
  6. Must be able to receive either the HeartWare® HVAD or control LVAD
  7. Patient must agree to participate in and comply with an improved blood pressure management program, including maintenance of a patient diary.
  8. Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
  9. The patient or legally authorized representative has signed the informed consent form

Exclusion Criteria:

  1. Body Mass Index (BMI) > 40
  2. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
  3. Prior cardiac transplant.
  4. History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm.
  5. Cardiothoracic surgery within 30 days of randomization.
  6. 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 ;.
  7. Patients eligible for cardiac transplantation
  8. On ventilator support for > 72 hours within the four days immediately prior to randomization and implant.
  9. Pulmonary embolus within three weeks of randomization as documented by computed tomography (CT) scan or nuclear scan.
  10. Symptomatic cerebrovascular disease, stroke within 180 days of randomization or > 80% stenosis of carotid or cranial vessels.
  11. Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant.
  12. 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 screening/randomization or right atrial pressure > 20 mmHg on multiple inotropes or right ventricular ejection fraction (RVEF) <15% with clinical signs of severe right heart failure (e.g. Lower extremity edema, ascites or pleural effusions refractory to treatment with diuretics and two inotropic drugs).
  13. 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.
  14. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, INR > 2.0 or PTT > 2.5 times control in the absence of anticoagulation therapy).
  15. 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.
  16. Serum creatinine > 3.0 mg/dL within 72 hours of randomization or requiring dialysis or ultrafiltration.
  17. Specific liver enzymes [AST (SGOT) and ALT (SGPT] > 3 times upper limit of normal within 72 hours of randomization.
  18. A total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver cirrhosis or portal hypertension.
  19. Pulmonary vascular resistance is demonstrated to be unresponsive to pharmacological manipulation and the PVR > 6 Wood units.
  20. Patients with a mechanical heart valve.
  21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy
  22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 <50%)
  23. Participation in any other study involving investigational drugs or devices
  24. Severe illness, other than heart disease, which would limit survival to < 3 years
  25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities
  26. Pregnancy
  27. Patient unwilling or unable to comply with study requirements
  28. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966458

Contact: Dawn Dyer ddyer@heartware.com

  Hide Study Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jennifer Drummonds    205-975-9319    jdrummonds@uab.edu   
Principal Investigator: Salpy Pamboukian, MD         
United States, Arizona
Mayo Clinic (Arizona) Recruiting
Phoenix, Arizona, United States, 85054
Contact: Sheena Lamon    480-342-3988    lamon.sheena@mayo.edu   
Principal Investigator: Octavio Pajaro, MD         
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Carmelita Runyan    310-423-2323    carmelita.runyan@cshs.org   
Principal Investigator: Jamie Moriguchi, MD         
The University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Tammie Possemato    323-442-6078    tpossema@usc.edu   
Principal Investigator: Michael Bowdish, MD         
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Marie Lugtu    650-498-9969    mlugtu@stanfordmed.org   
Principal Investigator: Philip Oyer, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington DC, District of Columbia, United States, 20010
Contact: Margaret Kildee    202-877-0613    Margaret.M.Kildee@Medstar.net   
Principal Investigator: Samer Najjar, MD         
United States, Florida
University of Florida Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Debra Robertson    352-273-5513    Debra.Robertson@surgery.ufl.edu   
Principal Investigator: Charles Klodell, MD         
University of Miami / Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Laura Hudson    305-243-5678    ljhudson@med.miami.edu   
Principal Investigator: Sandra Chaparro, MD         
Tampa Transplant Institute/Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Aimee Jopling    813-844-3432    AJopling@TGH.org   
Principal Investigator: Christiano Caldeira, MD         
United States, Georgia
The Emory Clinic Inc. Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jayne Thompson    404-778-4920    sjdanle@emory.edu   
Principal Investigator: David Vega, MD         
Saint Joseph Hospital of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Rebecca Allen    678-843-6081    rallen@sjha.org   
Principal Investigator: Jeffrey Miller, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Katherine Benes    312-695-0509    kbenes@nmh.org   
Principal Investigator: Patrick McCarthy, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Becki Pisarski    773-834-3791    bpisarski@surgery.bsd.uchicago.edu   
Principal Investigator: Valluvan Jeevanandam, MD         
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Colleen Gallagher    708-346-4040    colleen.gallagher@advocatehealth.com   
Principal Investigator: Antone Tatooles, MD         
United States, Indiana
IU Health Methodist Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Ann-Marie Thorp    317-962-9904    athorp2@iuhealth.org   
Principal Investigator: Thomas Wozniak, MD         
St. Vincent Health Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Regina Margiotti    317-338-6151    rmargiotti@thecaregroup.com   
Principal Investigator: Christopher Salerno, MD         
United States, Kentucky
Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Heather Moody    502-561-2180    hmoody@louisvilleheartsurgery.com   
Principal Investigator: Mark Slaughter, MD         
United States, Louisiana
John Ochsner Heart & Vascular Institute Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Shannon Williams    504-842-6487    slwilliams@ochsner.org   
Principal Investigator: Patrick Parrino, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Dene Palazzi-Khan    410-287-8610    dnoppen1@jhmi.edu   
Principal Investigator: Gerin Stevens, MD         
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Linda Romar    410-328-2737    lromar@smail.umaryland.edu   
Principal Investigator: Si Pham, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Ryan O'Kelly    617-636-4990    rokelly@tuftsmedicalcenter.org   
Principal Investigator: Duc Thinh Pham, MD         
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lydia McGowan    734-615-3068    lydiamcg@umich.edu   
Principal Investigator: Francis Pagani, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Crystal Bradley    313-916-1011    cbradle4@hfhs.org   
Principal Investigator: Robert Brewer, MD         
United States, Minnesota
Abbott Northwestern Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Laura Onstot    612-863-6120    laura.onstot@allina.com   
Principal Investigator: Barry Cabuay, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Carol Toninato    612-625-4914    ctoninato@umphysicians.umn.edu   
Principal Investigator: Ranjit John, MD         
Mayo Clinic / St. Marys Hospital Recruiting
Rochester, Minnesota, United States, 55902
Contact: Cathy Anderson Severson    507-255-2673    severson.cathy@mayo.edu   
Principal Investigator: Lyle Joyce, MD         
United States, Missouri
Washington University / Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Tracy Sutton    314-747-1926    suttont@wudosis.wustl.edu   
Principal Investigator: Akinobu Itoh, MD         
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Bhatri Patel    973-926-8451    bharapatel@barnabashealth.org   
Principal Investigator: Mark Zucker, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Roger Swayze    718-920-2221    rswayze@montefiore.org   
Principal Investigator: Daniel Goldstein, MD         
New York Presbyterian Hospital/Columbia Recruiting
New York, New York, United States, 10032
Contact: Katharine A. Idrissi    212-305-7087    kc286@columbia.edu   
Principal Investigator: Yoshifumi Naka, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Laura Blue    919-681-1779    blue0001@mc.duke.edu   
Principal Investigator: Carmelo Milano, MD         
United States, Ohio
Cleveland Clinic Foundatiojn Recruiting
Cleveland, Ohio, United States, 44195
Contact: Barbara Gus    216-445-6552    gusb@ccf.org   
Principal Investigator: Nader Moazami, MD         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Kelly MacBrair    614-366-7446    Kelly.MacBrair@osumc.edu   
Principal Investigator: C.B. Sai-Sudhakar, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Claudia Stone    503-494-4192    stonecl@ohsu.edu   
Principal Investigator: Howard Song, MD         
United States, Pennsylvania
Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Todd Nicklas    717-531-5966    tnicklas@hmc.psu.edu   
Principal Investigator: Christoph Brehm, MD         
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Emily Phillips    215-301-6986    Emily.Phillips@uphs.upenn.edu   
Principal Investigator: Michael Acker, MD         
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kathleen Lockard    412-802-8664    lockardk@upmc.edu   
Principal Investigator: Robert Kormos, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-8802
Contact: Mary Beth Davis    615-343-6189    mary.beth.davis@vanderbilt.edu   
Principal Investigator: Simon Maltais, MD         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Ali Kruger    214-818-1721    Alice.Kruger@baylorhealth.edu   
Principal Investigator: Gonzalo Gonzalez-Stawinski, MD         
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Mary Weyant    214-645-9708    Mary.Weyant@utsouthwestern.edu   
Principal Investigator: Dan Meyer, MD         
Texas Heart Institute Recruiting
Houston, Texas, United States, 77030
Contact: Sylvia A. Carranza    832-355-8524    SCarranza@texasheart.org   
Principal Investigator: Hari Mallidi, MD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Raquel R. Bunge    713-441-6509    rrbunge2@tmhs.org   
Principal Investigator: Brian Bruckner, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Marsha Eidson    801-408-8666    marsha.eidson@imail.org   
Principal Investigator: Bruce Reid, MD         
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Ashley Elmer    801-585-3118    Ashley.Elmer@hsc.utah.edu   
Principal Investigator: Craig Selzman, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Candace Hall    703-776-6028    Candace.Hall2@inova.org   
Principal Investigator: Anthony Rongione, MD         
Sentara Norfolk Recruiting
Norfolk, Virginia, United States, 23507
Contact: Rachel E Muñoz    757-388-7511    REOTTING@sentara.com   
Principal Investigator: Jonathan Philpott, MD         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Shauna Andrus    206-221-5895    sandrus@u.washington.edu   
Principal Investigator: Nahush Mokadam, MD         
Northwest Cardiothoracic &Transplant Surgeons Recruiting
Spokane, Washington, United States, 99204
Contact: Suzanne Puhlman    509-474-3822    suzanne.puhlman@providence.org   
Principal Investigator: Timothy Icenogle, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Cheryl A. Zywicki    414-385-2474    cheryl.zywicki@aurora.org   
Principal Investigator: Francis Downey, MD         
Sponsors and Collaborators
HeartWare, Inc.
Principal Investigator: Francis Pagani, MD University of Michigan Hospital
Principal Investigator: Joseph Rogers, MD Duke University
  More Information

No publications provided

Responsible Party: HeartWare, Inc.
ClinicalTrials.gov Identifier: NCT01966458     History of Changes
Other Study ID Numbers: HW004-A
Study First Received: October 17, 2013
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 27, 2015