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

Not Applicable

Completed

Conditions: Heart Failure, Congestive
Cardiomyopathies
Ventricular Dysfunction

Registration Number: NCT00121472

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 194

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survival	180 days	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).

Secondary Outcome Measures

Name	Time	Method
Post-transplant Survival	30 days, 1 year	30 day and 1 year post transplant survival
Minnesota Living With Heart Failure Questionnaire (MLWHF)	Baseline to 6 months	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.
Reoperations	continuous	Additional surgery after the initial implant operation
Kansas City Cardiomyopathy Questionaire (KCCQ)	baseline to 6 months	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.
New York Heart Association (NYHA) Classification	baseline, 1 month, 3 months, 6 months	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
Six Minute Walk Test (6MWT)	baseline to 6 months	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.
Clinical Reliability (Malfunctions/Failures)	continuous	Confirmed malfunctions/Serious Adverse Events

Trial Locations

Locations (36): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Mayo Clinic Hospital
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Phoenix, Arizona, United States
Sharp Memorial Hospital
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San Diego, California, United States
California Pacific Medical Center
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San Francisco, California, United States
Washington Hospital Center
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Washington, District of Columbia, United States
Shands Hospital @ University of Florida
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Gainesville, Florida, United States
Methodist Hospital
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Indianapolis, Indiana, United States
Jewish Hospital
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Louisville, Kentucky, United States
Johns Hopkins Hospital
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Baltimore, Maryland, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States