Clinical trial NCT00121485: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Ventricular Dysfunction
Cardiomyopathies
Keywords: Heart-assist devices
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2005-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite Endpoint
timeFrame: Patients' status at 2 years post-implant
Secondary outcomes:
measure: Minnesota Living With Heart Failure Questionnaire(MLWHF)
timeFrame: Baseline, Months 1,3,6,12
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline, Months 1, 3, 6, 12
measure: New York Heart Association (NYHA) Classification
timeFrame: Baseline, Months 1, 6, 12
measure: Six Minute Walk Test (6MWT)
timeFrame: Baseline, Months 1, 3, 6, 12
measure: Functional Status (Patient Activity Score)
timeFrame: Baseline, Months 1, 3, 6, 12
measure: Reoperations
timeFrame: Patients were followed until outcome or up to 2 years post-implant, whichever came first
measure: Neurocognitive Assessments, Clock Drawing
timeFrame: Baseline (1 month), 6 months
measure: Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
timeFrame: Baseline (1 month), 6 months
measure: Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
timeFrame: Baseline (1 month), 6 months
measure: Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
timeFrame: Baseline (1 month), 6 months
measure: Neurocognitive Assessments, Boston Naming Test
timeFrame: Baseline (1 month), 6 months
measure: Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
timeFrame: Baseline (1 month), 6 months
measure: Neurocognitive Assessments, Trail Making A
timeFrame: Baseline (1 month), 6 months
measure: Neurocognitive Assessments, Trail Making B
timeFrame: Baseline (1 month), 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands Hospital @ University of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts / New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital/Washington University
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York Columbia Presbyterian Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Milton Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of University of PA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Dallas
country: United States
facility: Medical City Hospital Dallas
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital (Intermountain Health Care)
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hospital Royal Victoria / McGill University Health Centre
state: Quebec
Study officials:
affiliation: Thoratec Corporation
name: Pooja Chatterjee
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.