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

Primary Purpose

Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Left Ventricular Assist System (LVAS)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Heart-assist devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Hospital
  • Sharp Memorial Hospital
  • California Pacific Medical Center
  • University of Colorado Hospital
  • Washington Hospital Center
  • Shands Hospital @ University of Florida
  • Tampa General Hospital
  • Emory University Hospital
  • Advocate Christ Medical Center
  • Methodist Hospital
  • Jewish Hospital
  • University of Maryland School of Medicine
  • Johns Hopkins Hospital
  • Tufts / New England Medical Center
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • University of Michigan
  • Henry Ford Health System
  • University of Minnesota
  • Mayo Clinic
  • Barnes-Jewish Hospital/Washington University
  • Bryan LGH Heart Institute
  • Newark Beth Israel Medical Center
  • Montefiore Medical Center
  • New York Columbia Presbyterian Medical Center
  • University of Rochester
  • Duke University Medical Center
  • Cleveland Clinic
  • Ohio State University
  • INTEGRIS Baptist Medical Center
  • Milton Hershey Medical Center
  • Hahnemann University Hospital
  • Hospital of University of PA
  • Allegheny General Hospital
  • University of Pittsburgh
  • Baptist Memorial Hospital
  • Medical City Hospital Dallas
  • Texas Heart Institute
  • LDS Hospital (Intermountain Health Care)
  • Sentara Norfolk General Hospital
  • University of Washington
  • Sacred Heart Medical Center
  • University of Wisconsin Medical School
  • St. Luke's Medical Center
  • Toronto General Hospital
  • Hospital Royal Victoria / McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HeartMate II

HeartMate XVE

Arm Description

Implantation of HeartMate II LVAS

Implantation of HeartMate XVE LVAS

Outcomes

Primary Outcome Measures

Composite Endpoint
Survival at two (2) years free of stroke, or reoperation to repair or replace the device

Secondary Outcome Measures

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.
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.
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
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.
Functional Status (Patient Activity Score)
Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
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
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.
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
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 12, 2005
Last Updated
June 23, 2022
Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00121485
Brief Title
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
Official Title
The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
Keywords
Heart-assist devices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HeartMate II
Arm Type
Experimental
Arm Description
Implantation of HeartMate II LVAS
Arm Title
HeartMate XVE
Arm Type
Active Comparator
Arm Description
Implantation of HeartMate XVE LVAS
Intervention Type
Device
Intervention Name(s)
Left Ventricular Assist System (LVAS)
Other Intervention Name(s)
Thoratec, HeartMate II, ventricular assist
Intervention Description
Implantation of left ventricular assist device for hemodynamic support
Primary Outcome Measure Information:
Title
Composite Endpoint
Description
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Time Frame
Patients' status at 2 years post-implant
Secondary Outcome Measure Information:
Title
Minnesota Living With Heart Failure Questionnaire(MLWHF)
Description
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.
Time Frame
Baseline, Months 1,3,6,12
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
Baseline, Months 1, 3, 6, 12
Title
New York Heart Association (NYHA) Classification
Description
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
Time Frame
Baseline, Months 1, 6, 12
Title
Six Minute Walk Test (6MWT)
Description
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.
Time Frame
Baseline, Months 1, 3, 6, 12
Title
Functional Status (Patient Activity Score)
Description
Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
Time Frame
Baseline, Months 1, 3, 6, 12
Title
Reoperations
Description
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
Time Frame
Patients were followed until outcome or up to 2 years post-implant, whichever came first
Title
Neurocognitive Assessments, Clock Drawing
Description
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.
Time Frame
Baseline (1 month), 6 months
Title
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
Description
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
Time Frame
Baseline (1 month), 6 months
Title
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
Description
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.
Time Frame
Baseline (1 month), 6 months
Title
Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
Description
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.
Time Frame
Baseline (1 month), 6 months
Title
Neurocognitive Assessments, Boston Naming Test
Description
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.
Time Frame
Baseline (1 month), 6 months
Title
Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
Description
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.
Time Frame
Baseline (1 month), 6 months
Title
Neurocognitive Assessments, Trail Making A
Description
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.
Time Frame
Baseline (1 month), 6 months
Title
Neurocognitive Assessments, Trail Making B
Description
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.
Time Frame
Baseline (1 month), 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Chatterjee
Organizational Affiliation
Thoratec Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Shands Hospital @ University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46206
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts / New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital/Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bryan LGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Milton Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Hospital of University of PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Medical City Hospital Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
LDS Hospital (Intermountain Health Care)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Wisconsin Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Hospital Royal Victoria / McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19920051
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 ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17. Erratum In: N Engl J Med. 2018 Aug 16;379(7):697.
Results Reference
result
PubMed Identifier
22153550
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 pulsatile-flow left ventricular assist device support. J Heart Lung Transplant. 2012 Jan;31(1):27-36. doi: 10.1016/j.healun.2011.10.012.
Results Reference
result
PubMed Identifier
22282104
Citation
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 therapy. Circ Heart Fail. 2012 Mar 1;5(2):241-8. doi: 10.1161/CIRCHEARTFAILURE.111.963991. Epub 2012 Jan 26.
Results Reference
result
PubMed Identifier
24750460
Citation
Brisco MA, Sundareswaran KS, Milano CA, Feldman D, Testani JM, Ewald GA, Slaughter MS, Farrar DJ, Goldberg LR; HeartMate II Clinical Investigators. Incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices. J Card Surg. 2014 Jul;29(4):572-80. doi: 10.1111/jocs.12336. Epub 2014 Apr 18.
Results Reference
derived

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

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