Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

Heart Failure, Congestive Clinical Trial

Official title:

The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121472
• Other study ID #: TC010230-1
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Est. completion date: May 2010

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 a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.

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. Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: May 2010
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

The following are general criteria; more specific conditions are included in the study

protocol:

• Listed for cardiac transplantation
• NYHA Class IV heart failure symptoms
• On inotropic support, if tolerated
• Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock 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:
• Thoratec HeartMate II Left Ventricular Assist System (LVAS)
Implantation of ventricular assist device to provide 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	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	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	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	Texas Heart Institute	Houston	Texas
United States	Methodist Hospital	Indianapolis	Indiana
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	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
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	University of Rochester	Rochester	New York
United States	Barnes-Jewish Hospital/Washington University	Saint Louis	Missouri
United States	LDS Hospital	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	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 (1)

Miller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, Conte JV, Naka Y, Mancini D, Delgado RM, MacGillivray TE, Farrar DJ, Frazier OH; HeartMate II Clinical Investigators. Use of a continuous-flow device in patients awaiting heart transplantati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).	180 days
Secondary	Clinical Reliability (Malfunctions/Failures)	Confirmed malfunctions/Serious Adverse Events	continuous
Secondary	Kansas City Cardiomyopathy Questionaire (KCCQ)	KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). 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 six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.	baseline to 6 months
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, 1 month, 3 months, 6 months
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' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.	Baseline to 6 months
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 to 6 months
Secondary	Reoperations	Additional surgery after the initial implant operation	continuous
Secondary	Post-transplant Survival	30 day and 1 year post transplant survival	30 days, 1 year