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Chronic Heart FailureDT2NCT01966458

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

A study testing HeartWare® VAS (HVAD) in people with Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
HeartWare® VAS (HVAD)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
494 participants
Where
47 sitesUnited States
Study dates
Oct 2013to Aug 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 ;.
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  • 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.
  • Serum creatinine > 3.0 mg/dL within 72 hours of randomization or requiring dialysis or ultrafiltration.
  • Specific liver enzymes [AST (SGOT) and ALT (SGPT] > 3 times upper limit of normal within 72 hours of randomization.
  • A total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver cirrhosis or portal hypertension.
  • Pulmonary vascular resistance is demonstrated to be unresponsive to pharmacological manipulation and the PVR > 6 Wood units.
  • Patients with a mechanical heart valve.
  • Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy
  • History of severe COPD or severe restrictive lung disease (e.g. FEV1 <50%)
  • Participation in any other study involving investigational drugs or devices
  • Severe illness, other than heart disease, which would limit survival to < 3 years
  • Peripheral vascular disease with rest pain or ischemic ulcers of the extremities
  • Pregnancy
  • Patient unwilling or unable to comply with study requirements
  • Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • The Emory Clinic Inc.

    Atlanta, Georgia, 30322

  • Saint Joseph Hospital of Atlanta

    Atlanta, Georgia, 30342

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundatiojn

    Cleveland, Ohio, 44195

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of Florida Gainesville

    Gainesville, Florida, 32610

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Texas Heart Institute

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • IU Health Methodist

    Indianapolis, Indiana, 46202

  • St. Vincent Health

    Indianapolis, Indiana, 46260

  • The University of Southern California

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • University of Miami / Jackson Memorial Hospital

    Miami, Florida, 33136

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern

    Minneapolis, Minnesota, 55407

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-8802

  • John Ochsner Heart & Vascular Institute

    New Orleans, Louisiana, 70115

  • New York Presbyterian Hospital/Columbia

    New York, New York, 10032

  • Sentara Norfolk

    Norfolk, Virginia, 23507

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic (Arizona)

    Phoenix, Arizona, 85054

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mayo Clinic / St. Marys Hospital

    Rochester, Minnesota, 55902

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Northwest Cardiothoracic &Transplant Surgeons

    Spokane, Washington, 99204

  • Washington University / Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Tampa Transplant Institute/Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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

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.

Read the detailed description

The study will evaluate non-inferiority of neurologic injury incidence in a new cohort of subjects receiving improved blood pressure management to a control group (i.e., any FDA-approved LVAD for destination therapy). Secondary endpoints include: a comparison of stroke/TIA incidence to a reference observed in the original IDE clinical trial (HW004) that did not specify improved blood pressure management; and non-inferiority of stroke-free success on the originally implanted device to the control group. 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 60 months post-implant.

Being tested
HeartWare® VAS (HVAD), Control LVAD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Control LVADDevice

    Any FDA-approved LVAD for destination therapy.

Study groups in NCT01966458
Study groupRoleWhat they receive
HeartWare® VAS (HVAD)ExperimentalImplant of HeartWare® Ventricular Assist System
Receives: Device: HeartWare® VAS (HVAD)
Control LVADActive comparatorImplant of FDA-approved LVAD approved for destination therapy
Receives: Device: Control LVAD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Implant to 12 Months

Secondary outcomes (2)

  1. Number of HeartWare VAS Participants With Stroke/TIA

    The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.

    Measured: Implant to 12 Months

  2. Number of Participants With Stroke-Free Success

    Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale >=4).

    Measured: Implant to 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionAug 2016
  4. Study completionAug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01966458
Sponsor's protocol ID
HW004-A
Acronym
DT2
Status last verified
Oct 2020
First submitted
17 Oct 2013
Last updated
23 Oct 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32740343

  • 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.

    PubMed 32740129

  • 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.

    PubMed 30007559

Questions about this trial

What is this clinical trial studying?

A study testing HeartWare® VAS (HVAD) in people with Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Neurologic Injury (time frame: Implant to 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01966458, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.

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