Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
- Conditions
- Heart Failure, CongestiveVentricular DysfunctionCardiomyopathies
- Interventions
- Device: Left Ventricular Assist System (LVAS)
- Registration Number
- NCT00121485
- 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 Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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%
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
- PARALLEL
- Arm && Interventions
Group Intervention Description HeartMate II Left Ventricular Assist System (LVAS) Implantation of HeartMate II LVAS HeartMate XVE Left Ventricular Assist System (LVAS) Implantation of HeartMate XVE LVAS
- Primary Outcome Measures
Name Time Method Composite Endpoint Patients' status at 2 years post-implant Survival at two (2) years free of stroke, or reoperation to repair or replace the device
- Secondary Outcome Measures
Name Time Method Kansas City Cardiomyopathy Questionnaire (KCCQ) Baseline, Months 1, 3, 6, 12 KCCQ is a validated instrument to self assess quality of life including physical function and social function. 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 Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life.
Six Minute Walk Test (6MWT) Baseline, Months 1, 3, 6, 12 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.
Functional Status (Patient Activity Score) Baseline, Months 1, 3, 6, 12 Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
Reoperations Patients were followed until outcome or up to 2 years post-implant, whichever came first The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons
Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) Baseline (1 month), 6 months The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better.
Neurocognitive Assessments, Trail Making B Baseline (1 month), 6 months This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better.
Minnesota Living With Heart Failure Questionnaire(MLWHF) Baseline, Months 1,3,6,12 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' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.
New York Heart Association (NYHA) Classification Baseline, Months 1, 6, 12 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
Neurocognitive Assessments, Clock Drawing Baseline (1 month), 6 months Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score.
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) Baseline (1 month), 6 months The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better
Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) Baseline (1 month), 6 months The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better.
Neurocognitive Assessments, Trail Making A Baseline (1 month), 6 months This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better.
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) Baseline (1 month), 6 months The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better.
Neurocognitive Assessments, Boston Naming Test Baseline (1 month), 6 months Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better.
Trial Locations
- Locations (47)
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Bryan LGH Heart Institute
🇺🇸Lincoln, Nebraska, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Tufts / New England Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Rochester
🇺🇸Rochester, New York, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Shands Hospital @ University of Florida
🇺🇸Gainesville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Barnes-Jewish Hospital/Washington University
🇺🇸Saint Louis, Missouri, United States
Milton Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
New York Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Hospital of University of PA
🇺🇸Philadelphia, Pennsylvania, United States
Medical City Hospital Dallas
🇺🇸Dallas, Texas, United States
LDS Hospital (Intermountain Health Care)
🇺🇸Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Hospital Royal Victoria / McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Montefiore Medical Center
🇺🇸Bronx, New York, United States