The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
Trial ID: NCT00121485
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2005-02
Completion date: 2012-01
Sponsor: Abbott Medical Devices
Collaborators: Thoratec Corporation
Conditions: Heart Failure, Congestive; Ventricular Dysfunction; Cardiomyopathies
Interventions: Left Ventricular Assist System (LVAS)
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; New York Columbia Presbyterian Medical Center; University of Rochester; Montefiore Medical Center; 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
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; Canada; Canada
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

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).

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

Outcomes:
Composite Endpoint