Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

Heart Failure, Congestive Clinical Trial

Official title:

The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121485
• Other study ID #: TC010230-2
• Status: Completed
• Phase: N/A
• Start date: February 2005
• Est. completion date: January 2012

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2012
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Heart Failure, Congestive
• Ventricular Dysfunction

Intervention

Device:
• Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support

Locations

Country	Name	City	State
Canada	Hospital Royal Victoria / McGill University Health Centre	Montreal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts / New England Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Medical City Hospital Dallas	Dallas	Texas
United States	University of Colorado Hospital	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Shands Hospital @ University of Florida	Gainesville	Florida
United States	Milton Hershey Medical Center	Hershey	Pennsylvania
United States	Texas Heart Institute	Houston	Texas
United States	Methodist Hospital	Indianapolis	Indiana
United States	Bryan LGH Heart Institute	Lincoln	Nebraska
United States	Jewish Hospital	Louisville	Kentucky
United States	University of Wisconsin Medical School	Madison	Wisconsin
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	New York Columbia Presbyterian Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Hospital of University of PA	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Barnes-Jewish Hospital/Washington University	Saint Louis	Missouri
United States	LDS Hospital (Intermountain Health Care)	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Park SJ, Milano CA, Tatooles AJ, Rogers JG, Adamson RM, Steidley DE, Ewald GA, Sundareswaran KS, Farrar DJ, Slaughter MS; HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination — View Citation

Petrucci RJ, Rogers JG, Blue L, Gallagher C, Russell SD, Dordunoo D, Jaski BE, Chillcott S, Sun B, Yanssens TL, Tatooles A, Koundakjian L, Farrar DJ, Slaughter MS. Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsat — View Citation

Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricula — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Endpoint	Survival at two (2) years free of stroke, or reoperation to repair or replace the device	Patients' status at 2 years post-implant
Secondary	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' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.	Baseline, Months 1,3,6,12
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	Baseline, Months 1, 3, 6, 12
Secondary	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, Months 1, 6, 12
Secondary	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, Months 1, 3, 6, 12
Secondary	Functional Status (Patient Activity Score)	Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High	Baseline, Months 1, 3, 6, 12
Secondary	Reoperations	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	Patients were followed until outcome or up to 2 years post-implant, whichever came first
Secondary	Neurocognitive Assessments, Clock Drawing	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.	Baseline (1 month), 6 months
Secondary	Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)	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	Baseline (1 month), 6 months
Secondary	Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)	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.	Baseline (1 month), 6 months
Secondary	Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)	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.	Baseline (1 month), 6 months
Secondary	Neurocognitive Assessments, Boston Naming Test	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.	Baseline (1 month), 6 months
Secondary	Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)	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.	Baseline (1 month), 6 months
Secondary	Neurocognitive Assessments, Trail Making A	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.	Baseline (1 month), 6 months
Secondary	Neurocognitive Assessments, Trail Making B	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.	Baseline (1 month), 6 months