The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial

NCT01166347 | Completed Results DMC

• 1 other identifier: HW004 ENDURANCE
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 48

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (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)

• Stroke-Free Survival Probability for 2 Years Post Implant

  The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale \>=4). 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. Weibull model estimates of survival probability (shown as a percent of 100) are used.

  Implant to 2 years

Secondary Outcomes (12)

• Number of Participants With Bleeding

  Implant to two years

• Number of Participants With Major Infections

  Implant to two years

• Overall Survival at 2 Years

  Implant to two years

• Number of Participants With Device Malfunctions

  Implant to two years

• Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Change from baseline to 2 years

Study Arms (2)

HeartWare® VAS

EXPERIMENTAL

Implant of HeartWare® Ventricular Assist System

Device: HeartWare® VAS

Control LVAD

ACTIVE COMPARATOR

Implant of FDA-approved LVADs approved for destination therapy

Device: Control LVAD

Interventions

HeartWare® VAS 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

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 (New York Heart Association (NYHA) Class IIIB or IV) who are: (patient must meet one of the following) 3a. 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 3b. In NYHA Class III or NYHA 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® VAS or control LVAD
• Female patients of childbearing potential must agree to use adequate contraceptive precautions 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
• 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
• 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) or right atrial pressure \> 20 mmHg on multiple inotropes, right ventricular ejection fraction (RVEF) \<15% or clinical signs
• Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing.
• 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 (48)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Hospital - Phoenix

Phoenix, Arizona, 85054, United States

Location

The University of Southern California

Los Angeles, California, 90033, United States

Location

Sharp Memorial

San Diego, California, 92123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Colorado Hospital - Leprino

Aurora, Colorado, 80045, 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

Saint 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

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

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St. Mary's Hospital - Mayo

Rochester, Minnesota, 55902, United States

Location

Washington University/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, 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 Foundation

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

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Texas - South Western

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

Innova Heart and Vascular Institute Research - Cardiac Vascular & Thoracic Surgery Associates, PC

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

Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (3)

• Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.

  PMID: 28146651 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

Related Links

• Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure

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: July 16, 2010
• First Posted: July 21, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2017
• Last Updated: September 6, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-09

Locations

US (48)