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

NCT01966458 | Completed Results DMC

• 1 other identifier: HW004-A
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 47

Brief Summary

This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Neurologic Injury

  The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) \> 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.

  Implant to 12 Months

Secondary Outcomes (2)

• Number of HeartWare VAS Participants With Stroke/TIA

  Implant to 12 Months

• Number of Participants With Stroke-Free Success

  Implant to 12 Months

Study Arms (2)

HeartWare® VAS (HVAD)

EXPERIMENTAL

Implant of HeartWare® Ventricular Assist System

Device: HeartWare® VAS (HVAD)

Control LVAD

ACTIVE COMPARATOR

Implant of FDA-approved LVAD approved for destination therapy

Device: Control LVAD

Interventions

HeartWare® VAS (HVAD) DEVICE

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.

HeartWare® VAS (HVAD)

Control LVAD DEVICE

Any FDA-approved LVAD for destination therapy.

Control LVAD

Eligibility Criteria

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

You may qualify if:

• Must be ≥18 years of age at consent
• Body Surface Area (BSA) ≥ 1.2 m2
• 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
• Left ventricular ejection fraction ≤ 25%
• LVAD implant is intended as destination therapy
• Must be able to receive either the HeartWare® HVAD or control LVAD
• Patient must agree to participate in and comply with an improved blood pressure management program, including maintenance of a patient diary.
• 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.
• The patient or legally authorized representative has signed the informed consent form

You may not qualify if:

• Body Mass Index (BMI) \> 40
• 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 randomization.
• 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 ;.
• Patients eligible for cardiac transplantation
• On ventilator support for \> 72 hours within the four days immediately prior to randomization and implant.
• Pulmonary embolus within three weeks of randomization as documented by computed tomography (CT) scan or nuclear scan.
• Symptomatic cerebrovascular disease, stroke within 180 days of randomization or \> 80% stenosis of carotid or cranial vessels.
• Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant.
• 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).
• 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 \< 75,000, INR \> 2.0 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (47)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic (Arizona)

Phoenix, Arizona, 85054, United States

Location

The University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, 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

Tampa Transplant Institute/Tampa General Hospital

Tampa, Florida, 33606, United States

Location

The Emory Clinic Inc.

Atlanta, Georgia, 30322, United States

Location

Saint Joseph Hospital of Atlanta

Atlanta, Georgia, 30342, 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

Louisville, Kentucky, 40202, United States

Location

John Ochsner Heart & Vascular Institute

New Orleans, Louisiana, 70115, United States

Location

University of Maryland

Baltimore, Maryland, 21201, 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

Abbott Northwestern

Minneapolis, Minnesota, 55407, 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

New York Presbyterian Hospital/Columbia

New York, New York, 10032, 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

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, 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

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk

Norfolk, Virginia, 23507, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Northwest Cardiothoracic &Transplant Surgeons

Spokane, Washington, 99204, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (3)

• 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

• Milano CA, Rogers JG, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Mokadam NA, Mahr C, Miller JS, Markham DW, Jeevanandam V, Uriel N, Aaronson KD, Vassiliades TA, Pagani FD; ENDURANCE Investigators. HVAD: The ENDURANCE Supplemental Trial. JACC Heart Fail. 2018 Sep;6(9):792-802. doi: 10.1016/j.jchf.2018.05.012. Epub 2018 Jul 11.

  PMID: 30007559 DERIVED

Results Point of Contact

• Title: Thomas Vassiliades
• Organization: Medtronic

thomas.a.vassiliades@medtronic.com

+15085321942

Study Officials

• Francis Pagani, MD

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

• Joseph Rogers, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 21, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2020
• Last Updated: October 23, 2020
• Results First Posted: April 23, 2018

Record last verified: 2020-10

Locations

US (47)