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Heart Failure, CongestiveNCT00121472

Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

A study testing Thoratec HeartMate II Left Ventricular Assist System (LVAS) in people with Heart Failure, Congestive and Ventricular Dysfunction, run by Abbott Medical Devices at 36 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. Read more about this study

Who is it for?
Any age
What is being tested?
Thoratec HeartMate II Left Ventricular Assist System (LVAS)
Type of treatment
Medical device
How many people
194 participants
Where
36 sitesin 2 countries
Study dates
Mar 2005to May 2010
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The following are general criteria; more specific conditions are included in the study protocol:
  • Listed for cardiac transplantation
  • NYHA Class IV heart failure symptoms
  • On inotropic support, if tolerated
  • Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock

Who cannot join

  • The following are general criteria; more specific conditions are included in the study protocol:
  • Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
  • Existence of factors that would adversely affect patient survival or function of the LVAS.
  • Intolerance to anticoagulant or antiplatelet therapies.
  • Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
  • Participation in any other clinical investigation that is likely to confound study results or affect study outcome.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States34 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43212

  • Medical City Hospital Dallas

    Dallas, Texas, 75230

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Shands Hospital @ University of Florida

    Gainesville, Florida, 32610

  • Texas Heart Institute

    Houston, Texas, 77030

  • Methodist Hospital

    Indianapolis, Indiana, 46206

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • University of Wisconsin Medical School

    Madison, Wisconsin, 53792

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • New York Columbia Presbyterian Medical Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23510

  • INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Hospital of University of PA

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester

    Rochester, New York, 14642

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • University of Washington

    Seattle, Washington, 98195

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Barnes-Jewish Hospital/Washington University

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Canada2 sites

  • Hospital Royal Victoria / McGill University Health Centre

    Montreal, Quebec, H3A 1A1

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

Official title: The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying.

The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.

Read the detailed description

The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver. Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices.

Being tested
Thoratec HeartMate II Left Ventricular Assist System (LVAS)
Keywords
Heart-assist devices
Medical subject headings
Heart Failure, Ventricular Dysfunction, Cardiomyopathies

What participants receive

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

  • Thoratec HeartMate II Left Ventricular Assist System (LVAS)Device

    Also called Thoratec, HeartMate II, Ventricular assist

    Implantation of ventricular assist device to provide hemodynamic support

What is being measured

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

  1. Survival

    Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).

    Measured: 180 days

Secondary outcomes (7)

  1. Clinical Reliability (Malfunctions/Failures)

    Confirmed malfunctions/Serious Adverse Events

    Measured: continuous

  2. Kansas City Cardiomyopathy Questionaire (KCCQ)

    KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.

    Measured: baseline to 6 months

  3. New York Heart Association (NYHA) Classification

    NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort

    Measured: baseline, 1 month, 3 months, 6 months

  4. Minnesota Living With Heart Failure Questionnaire (MLWHF)

    MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.

    Measured: Baseline to 6 months

  5. Six Minute Walk Test (6MWT)

    The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.

    Measured: baseline to 6 months

  6. Reoperations

    Additional surgery after the initial implant operation

    Measured: continuous

  7. Post-transplant Survival

    30 day and 1 year post transplant survival

    Measured: 30 days, 1 year

Timeline

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

  1. First posted21 Jul 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionNov 2006
  4. Study completionMay 2010

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121472
Sponsor's protocol ID
TC010230-1
Status last verified
Jun 2022
First submitted
12 Jul 2005
Last updated
27 Jun 2022
Data monitoring committee
Yes

Publications

  • Miller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, Conte JV, Naka Y, Mancini D, Delgado RM, MacGillivray TE, Farrar DJ, Frazier OH; HeartMate II Clinical Investigators. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. 2007 Aug 30;357(9):885-96. doi: 10.1056/NEJMoa067758.

    PubMed 17761592

  • Brisco MA, Sundareswaran KS, Milano CA, Feldman D, Testani JM, Ewald GA, Slaughter MS, Farrar DJ, Goldberg LR; HeartMate II Clinical Investigators. Incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices. J Card Surg. 2014 Jul;29(4):572-80. doi: 10.1111/jocs.12336. Epub 2014 Apr 18.

    PubMed 24750460

  • Russell SD, Rogers JG, Milano CA, Dyke DB, Pagani FD, Aranda JM, Klodell CT Jr, Boyle AJ, John R, Chen L, Massey HT, Farrar DJ, Conte JV; HeartMate II Clinical Investigators. Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device. Circulation. 2009 Dec 8;120(23):2352-7. doi: 10.1161/CIRCULATIONAHA.108.814863. Epub 2009 Nov 23.

    PubMed 19933938

  • Pagani FD, Miller LW, Russell SD, Aaronson KD, John R, Boyle AJ, Conte JV, Bogaev RC, MacGillivray TE, Naka Y, Mancini D, Massey HT, Chen L, Klodell CT, Aranda JM, Moazami N, Ewald GA, Farrar DJ, Frazier OH; HeartMate II Investigators. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009 Jul 21;54(4):312-21. doi: 10.1016/j.jacc.2009.03.055.

    PubMed 19608028

Questions about this trial

What is this clinical trial studying?

A study testing Thoratec HeartMate II Left Ventricular Assist System (LVAS) in people with Heart Failure, Congestive and Ventricular Dysfunction, run by Abbott Medical Devices at 36 sites in 2 countries.

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 5 inclusion and 6 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada. 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 19 Mar 2013). 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?

Survival (time frame: 180 days). 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 NCT00121472, which also lists 4 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 27 Jun 2022.

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