NCT00121472

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
2 countries

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

March 19, 2013

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

July 12, 2005

Results QC Date

May 29, 2009

Last Update Submit

June 23, 2022

Conditions

Heart Failure, CongestiveVentricular DysfunctionCardiomyopathies

Keywords

Heart-assist devices

Outcome Measures

Primary Outcomes (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).

    180 days

Secondary Outcomes (7)

  • Clinical Reliability (Malfunctions/Failures)

    continuous

  • Kansas City Cardiomyopathy Questionaire (KCCQ)

    baseline to 6 months

  • New York Heart Association (NYHA) Classification

    baseline, 1 month, 3 months, 6 months

  • Minnesota Living With Heart Failure Questionnaire (MLWHF)

    Baseline to 6 months

  • Six Minute Walk Test (6MWT)

    baseline to 6 months

  • +2 more secondary outcomes

Interventions

Thoratec HeartMate II Left Ventricular Assist System (LVAS)DEVICE

Implantation of ventricular assist device to provide hemodynamic support

Also known as: Thoratec, HeartMate II, Ventricular assist

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Shands Hospital @ University of Florida

Gainesville, Florida, 32610, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46206, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Barnes-Jewish Hospital/Washington University

St Louis, Missouri, 63110, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

New York Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, 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

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43212, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Hospital of University of PA

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Medical City Hospital Dallas

Dallas, Texas, 75230, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23510, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

University of Wisconsin Medical School

Madison, Wisconsin, 53792, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Hospital Royal Victoria / McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (4)

  • 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.

    PMID: 17761592RESULT

  • 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.

    PMID: 24750460DERIVED

  • 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.

    PMID: 19933938DERIVED

  • 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.

    PMID: 19608028DERIVED

MeSH Terms

Conditions

Heart FailureVentricular DysfunctionCardiomyopathies

Interventions

Heart-Assist Devices

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Assisted CirculationSurgical Procedures, OperativeHeart, ArtificialProstheses and ImplantsEquipment and SuppliesArtificial OrgansSurgical Equipment

Results Point of Contact

Title
Poornima Sood, MD, MBA, Sr. Director, Clinical Affairs
Organization
Thoratec Corporation
psood@thoratec.com
(781) 852-8334

Study Officials

  • Pooja Chatterjee

    Thoratec Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 21, 2005

Study Start

March 1, 2005

Primary Completion

November 1, 2006

Study Completion

May 1, 2010

Last Updated

June 27, 2022

Results First Posted

March 19, 2013

Record last verified: 2022-06

Locations

CA(2)US(34)