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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation

Conditions
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Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies

Intervention / Treatment
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* Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)|Implantation of ventricular assist device to provide hemodynamic support|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart-assist devices