Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy - Full Text View

Sponsored by:	Thoratec Corporation
Information provided by:	Thoratec Corporation
ClinicalTrials.gov Identifier:	NCT00121485

Purpose

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.

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

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:

Survival to two (2) years free of: stroke, or reoperation to repair or replace the device [ Time Frame: continuous ] [ Designated as safety issue: Yes ]

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 ]

Estimated Enrollment:	260
Study Start Date:	February 2005
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HeartMate II: Experimental Implantation of HeartMate II LVAS	Device: Left Ventricular Assist System (LVAS) Implantation of left ventricular assist device for hemodynamic support
HeartMate XVE: Active Comparator Implantation of HeartMate XVE LVAS	Device: Left Ventricular Assist System (LVAS) Implantation of left ventricular assist device for hemodynamic support

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.

The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.

Eligibility

Ages Eligible for Study:	18 Years and older
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:

Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
- On optimal medical management and are failing to respond; or
- In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
- Treated with ACE inhibitors or beta-blockers and found to be intolerant.
Ineligible for cardiac transplant
VO2max <=14 ml/kg/min
LVEF <=25%

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: NCT00121485

Contacts

Contact: Laura Damme, RN, MPH

781-272-0139 ext 2415

laura.damme@thoratec.com

Show 47 Study Locations

Sponsors and Collaborators

Thoratec Corporation

Investigators

Study Director:

Laura Damme

Thoratec Corporation

More Information

Responsible Party:	Thoratec Corporation ( Laura Damme, Sr. Director, Clinical Affairs )
Study ID Numbers:	TC010230-2
Study First Received:	July 12, 2005
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00121485
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thoratec Corporation:

Heart-assist devices

Study placed in the following topic categories:

Ventricular Dysfunction
Heart Failure
Heart Diseases
Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009