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

NCT ID: NCT00121472

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2010-05-31

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.

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.

Conditions

Heart Failure, Congestive; Ventricular Dysfunction; Cardiomyopathies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Thoratec HeartMate II Left Ventricular Assist System (LVAS)

Implantation of ventricular assist device to provide hemodynamic support

Intervention Type: DEVICE

Other Intervention Names

Thoratec; HeartMate II; Ventricular assist

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thoratec Corporation

INDUSTRY

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pooja Chatterjee

Role: STUDY_DIRECTOR

Thoratec Corporation

Locations

Baptist Memorial Hospital

Memphis, Tennessee, United States

Medical City Hospital Dallas

Dallas, Texas, United States

Texas Heart Institute

Houston, Texas, United States

LDS Hospital

Salt Lake City, Utah, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

University of Washington

Seattle, Washington, United States

Sacred Heart Medical Center

Spokane, Washington, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

Sharp Memorial Hospital

San Diego, California, United States

California Pacific Medical Center

San Francisco, California, United States

Washington Hospital Center

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

Shands Hospital @ University of Florida

Gainesville, Florida, United States

Methodist Hospital

Indianapolis, Indiana, United States

Jewish Hospital

Louisville, Kentucky, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Barnes-Jewish Hospital/Washington University

St Louis, Missouri, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

New York Columbia Presbyterian Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Hospital of University of PA

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Wisconsin Medical School

Madison, Wisconsin, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Toronto General Hospital

Toronto, Ontario, Canada

Hospital Royal Victoria / McGill University Health Centre

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 17761592 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24750460 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19933938 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19608028 (View on PubMed)

Other Identifiers

TC010230-1

Identifier Type: -

Identifier Source: org_study_id