Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation - Full Text View

Sponsor:	Thoratec Corporation
Information provided by:	Thoratec Corporation
ClinicalTrials.gov Identifier:	NCT00121472

Purpose

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). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome. Canadian study sites continue enrollment pending review and approval of Canada Medical Device License application.

Condition	Intervention
Heart Failure, Congestive Ventricular Dysfunction Cardiomyopathies	Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)

Thoratec Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Heart Failure Heart Transplantation

U.S. FDA Resources

Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:

Survival to cardiac transplantation or 180 days on LVAS support while remaining listed as status 1A or 1B. [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of adverse events [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Clinical reliability (malfunctions/failures) [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
Functional status [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
Reoperations [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Neurocognitive assessments [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
Post-transplant survival [ Time Frame: 30 days, 1 year ] [ Designated as safety issue: No ]

Enrollment:	484
Study Start Date:	February 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Implantation of ventricular assist device to provide hemodynamic support

Other Names:

Thoratec
HeartMate II
Ventricular assist

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121472

Show 36 Study Locations

Sponsors and Collaborators

Thoratec Corporation

Investigators

Study Director:

Laura Damme

Thoratec Corporation

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Nov 23.

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.

Responsible Party:	Laura Damme, Sr. Director, Clinical Affairs, Thoratec Corporation
ClinicalTrials.gov Identifier:	NCT00121472 History of Changes
Other Study ID Numbers:	TC010230-1
Study First Received:	July 12, 2005
Last Updated:	April 25, 2008
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Thoratec Corporation:

Heart-assist devices

Additional relevant MeSH terms:

Heart Failure
Ventricular Dysfunction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012