Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
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.
|Heart Failure, Congestive Ventricular Dysfunction Cardiomyopathies||Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation|
- Survival [ Time Frame: 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).
- Clinical Reliability (Malfunctions/Failures) [ Time Frame: continuous ]Confirmed malfunctions/Serious Adverse Events
- Kansas City Cardiomyopathy Questionaire (KCCQ) [ Time Frame: 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 [ Time Frame: 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
- Minnesota Living With Heart Failure Questionnaire (MLWHF) [ Time Frame: 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.
- Six Minute Walk Test (6MWT) [ Time Frame: 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.
- Reoperations [ Time Frame: continuous ]Additional surgery after the initial implant operation
- Post-transplant Survival [ Time Frame: 30 days, 1 year ]30 day and 1 year post transplant survival
|Study Start Date:||March 2005|
|Study Completion Date:||May 2010|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- HeartMate II
- Ventricular assist
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121472
Show 36 Study Locations
|Study Director:||Poornima Sood, MD, MBA||Thoratec Corporation|