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Ventricular Septal Defects |
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Clinical Trial: Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
This study is currently recruiting patients.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Heart Failure, Congestive Ventricular Dysfunction Cardiomyopathies | Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Phase II Phase III |
MedlinePlus related topics: Cardiomyopathy; Heart Diseases; Heart Failure
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
Further Study Details:
Primary Outcomes: Survival to two (2) years free of: stroke, or reoperation to repair or replace the device
Secondary Outcomes: Incidence of adverse events; Clinical reliability (malfunctions/failures); Quality of Life; Functional status; Reoperations; Neurocognitive assessments; Post-transplant survival at 30 days and 1 year
Expected Total Enrollment: 200
Secondary Outcomes: Incidence of adverse events; Clinical reliability (malfunctions/failures); Quality of Life; Functional status; Reoperations; Neurocognitive assessments; Post-transplant survival at 30 days and 1 year
Expected Total Enrollment: 200
Study start: February 2005
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00121485
Laura Damme, RN, MPH 781-272-0139 Ext. 2415 laura.damme@thoratec.com
California
Sharp Memorial Hospital, San Diego, California, 92123, United States; Recruiting
Walter Dembitsky, MD 858-541-6830 dembitsky@aol.com
Walter Dembitsky, MD, Principal Investigator
Brian Jaski, MD, Sub-Investigator
Walter Dembitsky, MD, Principal Investigator
Brian Jaski, MD, Sub-Investigator
California Pacific Medical Center, San Francisco, California, 94115, United States; Not yet recruiting
Soon Park, MD 415-600-1386 parks@sutterhealth.org
Soon Park, MD, Principal Investigator
Ernest Haeusslein, MD, Sub-Investigator
Soon Park, MD, Principal Investigator
Ernest Haeusslein, MD, Sub-Investigator
Florida
Shands Hospital @ University of Florida, Gainesville, Florida, 32610, United States; Recruiting
Charles Klodell, MD 352-846-0362 klodect@surgery.ufl.edu
Charles Klodell, MD, Principal Investigator
Juan Aranda, MD, Sub-Investigator
Charles Klodell, MD, Principal Investigator
Juan Aranda, MD, Sub-Investigator
Illinois
Advocate Christ Medical Center, Oak Lawn, Illinois, 60453, United States; Recruiting
Mark Slaughter, MD 708-346-4040 mscabg@aol.com
Mark Slaughter, MD, Principal Investigator
Marc Silver, MD, Sub-Investigator
Mark Slaughter, MD, Principal Investigator
Marc Silver, MD, Sub-Investigator
Indiana
Methodist Hospital, Indianapolis, Indiana, 46206, United States; Recruiting
Thomas Wozniak, MD 317-962-5888 twozniak@clarian.org
Waqas Ghumman, MD, Sub-Investigator
Thomas Wozniak, MD, Principal Investigator
Waqas Ghumman, MD, Sub-Investigator
Thomas Wozniak, MD, Principal Investigator
Kentucky
Jewish Hospital, Louisville, Kentucky, 40202, United States; Recruiting
Robert Dowling, MD 502-561-2180 rdowling@ucsamd.com
Robert Dowling, MD, Principal Investigator
Laman Gray, MD, Principal Investigator
Robert Dowling, MD, Principal Investigator
Laman Gray, MD, Principal Investigator
Maryland
Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States; Recruiting
John Conte, MD 410-955-1753 jconte@csurg.jhmi.jhu.edu
John Conte, MD, Principal Investigator
Stuart Russell, MD, Sub-Investigator
John Conte, MD, Principal Investigator
Stuart Russell, MD, Sub-Investigator
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Thomas MacGillivray, MD, Principal Investigator
Marc Semigran, MD, Sub-Investigator
Marc Semigran, MD, Sub-Investigator
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States; Recruiting
Frances Pagani, MD, Principal Investigator
Keith Aaronson, MD, Sub-Investigator
Keith Aaronson, MD, Sub-Investigator
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States; Recruiting
Ranjit John, MD 612-626-3664 johnx008@umn.edu
Ranjit John, MD, Principal Investigator
Leslie Miller, MD, Sub-Investigator
Andrew Boyle, MD, Sub-Investigator
Lyle Joyce, MD, Sub-Investigator
Monica Colvin-Adams, MD, Sub-Investigator
Ken Liao, MD, Sub-Investigator
Emil Missov, MD, Sub-Investigator
Ranjit John, MD, Principal Investigator
Leslie Miller, MD, Sub-Investigator
Andrew Boyle, MD, Sub-Investigator
Lyle Joyce, MD, Sub-Investigator
Monica Colvin-Adams, MD, Sub-Investigator
Ken Liao, MD, Sub-Investigator
Emil Missov, MD, Sub-Investigator
Missouri
Barnes-Jewish Hospital/Washington University, St. Louis, Missouri, 63110, United States; Recruiting
Nadar Moazami, MD 314-362-8008 moazamin@msnotes.wustl.edu
Nadar Moazami, MD, Principal Investigator
Gregory Ewald, MD, Sub-Investigator
Nadar Moazami, MD, Principal Investigator
Gregory Ewald, MD, Sub-Investigator
New York
New York Columbia Presbyterian Medical Center, New York, New York, 10032, United States; Recruiting
Yohsifumi Naka, MD 212-305-0828 yn33@columbia.edu
Yohsifumi Naka, MD, Principal Investigator
Simon Maybaum, MD, Sub-Investigator
Yohsifumi Naka, MD, Principal Investigator
Simon Maybaum, MD, Sub-Investigator
University of Rochester, Rochester, New York, 14642, United States; Recruiting
Todd Massey, MD 585-275-6964 todd_massey@nrmc.rochester.edu
Todd Massey, MD, Principal Investigator
Leway Chen, MD, Sub-Investigator
Todd Massey, MD, Principal Investigator
Leway Chen, MD, Sub-Investigator
Montefiore Medical Center, Bronx, New York, 10467, United States; Not yet recruiting
Robert Michler, MD 781-920-2100 rmichler@montefiore.org
Robert Michler, MD, Principal Investigator
Daniel Goldstein, MD, Sub-Investigator
Robert Michler, MD, Principal Investigator
Daniel Goldstein, MD, Sub-Investigator
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting
Carmelo Milano, MD 919-684-3243 milan002@mc.duke.edu
Carmelo Milano, MD, Principal Investigator
Joseph Rogers, MD, Sub-Investigator
Carmelo Milano, MD, Principal Investigator
Joseph Rogers, MD, Sub-Investigator
Ohio
Cleveland Clinic, Cleveland, Ohio, 43210, United States; Recruiting
Nicholas Smedira, MD 216-445-7053 smedira@ccf.org
Nicholas Smedira, MD, Principal Investigator
Randall Starling, MD, MPH, Sub-Investigator
Nicholas Smedira, MD, Principal Investigator
Randall Starling, MD, MPH, Sub-Investigator
Ohio State University, Columbus, Ohio, 43210, United States; Recruiting
Benjamin Sun, MD 614-293-4967 sun-3@medctr.osu.edu
Benjamin Sun, MD, Principal Investigator
David Feldman, MD, Sub-Investigator
John Sirak, MD, Sub-Investigator
Benjamin Sun, MD, Principal Investigator
David Feldman, MD, Sub-Investigator
John Sirak, MD, Sub-Investigator
Pennsylvania
Hospital of University of PA, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Michael Acker, MD 215-349-8305 michael.acker@uphs.upenn.edu
Michael Acker, MD, Principal Investigator
Shashank Desai, MD, Sub-Investigator
Michael Acker, MD, Principal Investigator
Shashank Desai, MD, Sub-Investigator
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Robert Kormos, MD 412-648-6259 kormosrl@msx.upmc.edu
Robert Kormos, MD, Principal Investigator
Robert Kormos, MD, Principal Investigator
Tennessee
Baptist Memorial Hospital, Memphis, Tennessee, 38120, United States; Recruiting
Edward Garrett, MD 901-747-3066 egarrettmd@cvscliic.com
Edward Garrett, MD, Principal Investigator
Todd Edwards, MD, Sub-Investigator
Edward Garrett, MD, Principal Investigator
Todd Edwards, MD, Sub-Investigator
Texas
Texas Heart Institute, Houston, Texas, 77030, United States; Recruiting
O.H. Frazier, MD 832-355-3005 knowlin@heart.thi.tmc.edu
O.H. Frazier, MD, Principal Investigator
Frank Smart, MD, Sub-Investigator
Reynolds Delgado, MD, Sub-Investigator
Igor Gregoric, MD, Sub-Investigator
O.H. Frazier, MD, Principal Investigator
Frank Smart, MD, Sub-Investigator
Reynolds Delgado, MD, Sub-Investigator
Igor Gregoric, MD, Sub-Investigator
Medical City Hospital Dallas, Dallas, Texas, 75230, United States; Recruiting
Todd Dewey, MD 972-566-4866 tdewey@csant.com
Todd Dewey, MD, Principal Investigator
Mitchell Magee, MD, Sub-Investigator
Todd Dewey, MD, Principal Investigator
Mitchell Magee, MD, Sub-Investigator
Utah
LDS Hospital, Salt Lake City, Utah, 84143, United States; Recruiting
James Long, MD 801-408-8666 jimlong@ihc.com
James Long, MD, Principal Investigator
Karl Nelson, MD, Sub-Investigator
James Long, MD, Principal Investigator
Karl Nelson, MD, Sub-Investigator
Washington
Sacred Heart Medical Center, Spokane, Washington, 99220, United States; Recruiting
Timothy Icenogle, MD 509-623-7575 mwcardtx@msn.com
Timothy Icenogle, MD, Principal Investigator
Timothy Icenogle, MD, Principal Investigator
University of Washington, Seattle, Washington, 98195, United States; Recruiting
Christopher Salerno, MD 206-543-3093 csalerno@u.washington.edu
Christopher Salerno, MD, Principal Investigator
Daniel Fishbein, MD, Sub-Investigator
Christopher Salerno, MD, Principal Investigator
Daniel Fishbein, MD, Sub-Investigator
More Information
Study ID Numbers: TC010230-2
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 20, 2005
ClinicalTrials.gov Identifier: NCT00121485
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 20, 2005
ClinicalTrials.gov Identifier: NCT00121485
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- Ventricular Septal Defects (Cleveland Clinic)
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