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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by HeartWare, Inc.
Sponsor:
Information provided by (Responsible Party):
HeartWare, Inc.
ClinicalTrials.gov Identifier:
NCT01966458
First received: October 17, 2013
Last updated: May 2, 2014
Last verified: October 2013
  Purpose

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).


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:
  • Change in stroke incidence at 12 months on the originally implanted HVAD in a new cohort of subjects receiving optimal blood pressure management. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stroke Free Success [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 429
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.

  Eligibility

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

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

Contacts
Contact: Dawn Dyer ddyer@heartware.com

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham Not yet 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) Active, not recruiting
Phoenix, Arizona, United States, 85054
United States, California
Cedars Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
The University of Southern California Active, not recruiting
Los Angeles, California, United States, 90033
Sharp Memorial Not yet recruiting
San Diego, California, United States, 92123
Contact: Suzanne Chillcott    858-939-3863    suzanne.chillcott@sharp.com   
Principal Investigator: Walter Dembitsky, MD         
Stanford University School of Medicine Not yet recruiting
Stanford, California, United States, 94305
Contact: Julie A. Shinn    650-723-7319    jshinn@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: Natia Parunashvili    202-877-9328    natia.parunashvili@medstar.net   
Principal Investigator: Samer Najjar, MD         
United States, Florida
University of Florida Gainesville Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Nancy Staples    352-273-5496    staplnl@surgery.ufl.edu   
Principal Investigator: Charles Klodell, MD         
University of Miami / Jackson Memorial Hospital Not yet 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 Active, not recruiting
Tampa, Florida, United States, 33606
United States, Georgia
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         
The Emory Clinic Inc. Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Tracy Valeroso    773-834-9021    tvaleros@surgery.bsd.uchicago.edu   
Principal Investigator: Valluvan Jeevanandam, MD         
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Tanisha Abraham    312-926-0846    tabraha1@nmh.org   
Principal Investigator: Edwin McGee, MD         
Cardiothoracic & Vascular Surgical Associates Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Colleen Gallagher    708-346-4044 ext 27    colleen.gallagher@advocatehealth.com   
Principal Investigator: Antone Tatooles, 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 Thorpe    317-962-9904    athorpe2@iuhealth.org   
Principal Investigator: Thomas Wozniak, MD         
St. Vincent Health Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Jewish Hospital Not yet 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 Not yet 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 Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Melanie Her    410-955-3597    mherr@jhmi.edu   
Principal Investigator: Gerin Stevens, MD         
University of Maryland Not yet 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 Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Abbott Northwestern Active, not recruiting
Minneapolis, Minnesota, United States, 55407
University of Minnesota Not yet 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: Scott Silvestry, MD         
United States, New Jersey
Newark Beth Israel Medical Center Not yet 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: Gillian Morgan    718-920-6742    gimorgan@montefiore.org   
Principal Investigator: Daniel Goldstein, MD         
New York Presbyterian Hospital/Columbia Active, not recruiting
New York, New York, United States, 10032
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 Active, not recruiting
Cleveland, Ohio, United States, 44195
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 Not yet 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 Active, not recruiting
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dale Kobrin    215-300-7456    Dale.Kobrin@uphs.upenn.edu   
Principal Investigator: Michael Acker, MD         
UPMC Presbyterian Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor University Medical Center Active, not recruiting
Dallas, Texas, United States, 75246
UT Southwestern Medical Center at Dallas Active, not recruiting
Dallas, Texas, United States, 75390
Texas Heart Institute Not yet recruiting
Houston, Texas, United States, 77030
Contact: Sylvia A. Carranza    832-355-8524    SCarranza@texasheart.org   
Principal Investigator: Hari Mallidi, MD         
The Methodist Hospital Not yet 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 Active, not recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
Inova Fairfax Hospital Active, not recruiting
Falls Church, Virginia, United States, 22042
Sentara Norfolk Active, not recruiting
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington Medical Center Not yet 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 Active, not recruiting
Spokane, Washington, United States, 99204
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.
Investigators
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 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014