This study is currently recruiting participants. Verified by Ventracor, January 2008
Sponsors and Collaborators: Ventracor International Center for Health Outcomes and Innovation Research
Information provided by: Ventracor ClinicalTrials.gov Identifier: NCT00490321
Purpose The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.
This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
Condition Intervention Phase End-Stage Heart Failure Cardiomyopathies Device: VentrAssistTM Left Ventricular Assist Device Phase III
Genetics Home Reference related topics: Cardiomyopathy
MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources
Study Type: Interventional Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy
Further study details as provided by Ventracor:
Primary Outcome Measures: Module A: Survival without a disabling stroke.
Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.
Secondary Outcome Measures: •Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment
Estimated Enrollment: 225 Study Start Date: June 2007 Estimated Study Completion Date: June 2012
Detailed Description: Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.
Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):
Eligible for either the VentrAssist or an FDA-approved DT LVAD LVEF <=25% Stage D heart failure Ineligible for cardiac transplantation Treated with standard heart failure therapy Exclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):
Contraindication to LVAD implantation Contraindication to anticoagulant or anti-platelet agents. Pre-existing mechanical circulatory support other than intra-aortic balloon pump Therapy with an investigational intervention at the time of screening A condition, other than heart failure, which would limit survival to less than 2 years Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490321
United States, Alabama University of Alabama Recruiting Birmingham, Alabama, United States, 35294 Contact: Salpy Pamboukian, MD [email protected] Contact: Peggy Blood, RN, MSN 205-975-0442 [email protected] Sub-Investigator: Jim Kirklin, MD Principal Investigator: Salpy Pamboukian, MD
United States, Florida University of Florida Recruiting Gainesville, Florida, United States, 32610 Contact: Charles Klodell, MD 352-273-5470 [email protected] Contact: Nancy Staples 352-273-5496 [email protected] Principal Investigator: Charles Klodell, MD Sub-Investigator: Juan Aranda, MD
United States, Illinois Northwestern University Recruiting Chicago, Illinois, United States, 60611 Contact: John O'Connell, MD 312-695-0008 [email protected] Contact: Nancy Schoenecker, RN, CCRC 312-695-18-6 [email protected] Sub-Investigator: John O'Connell, MD Principal Investigator: Edwin McGee, MD
United States, Indiana St. Vincent's Recruiting Indianapolis, Indiana, United States, 46260 Contact: Chris Salerno, MD 317-583-7600 [email protected] Contact: Mary Anne Gfell 317-583-7812 [email protected] Principal Investigator: Chris Salerno, MD Sub-Investigator: Mary Norine Walsh, MD
United States, Maryland University of Maryland School of Medicine Recruiting Baltimore, Maryland, United States, 21201 Contact: Bartley Griffith, MD 410-328-3822 [email protected] Contact: Erik Sorenson, PhD 410-328-2737 [email protected] Principal Investigator: Bartley Griffith, MD
United States, Minnesota University of Minnesota Recruiting Minneapolis, Minnesota, United States, 55455 Contact: Lyle Joyce, MD 612-624-8130 [email protected] Contact: Andrew Boyle, MD 612-625-7924 [email protected] Principal Investigator: Lyle Joyce, MD Principal Investigator: Andrew Boyle, MD Mayo Clinic Recruiting Rochester, Minnesota, United States, 55904 Contact: Soon Park, MD [email protected] Contact: Mark McClees 507-538-2857 [email protected] Principal Investigator: Soon Park, MD Sub-Investigator: Margaret Redfield, MD
United States, Missouri Washington University School of Medicine Recruiting St. Louis, Missouri, United States, 63110 Contact: Nader Moazami, MD 314-362-8008 [email protected] Contact: Kim Shelton, RN, BSN 314-454-8691 [email protected] Principal Investigator: Nader Moazami, MD Sub-Investigator: Greg Ewald, MD
United States, New York Columbia University Recruiting New York, New York, United States, 10032 Contact: Yoshifumi Naka, MD 212-305-2439 [email protected] Contact: Margaret Flannery, RN 212-305-2439 [email protected] Principal Investigator: Yoshifumi Naka, MD Sub-Investigator: Mario Deng, MD Montefiore Medical Center Recruiting Bronx, New York, United States, 10467 Contact: Daniel Goldstein, MD 718-920-2144 [email protected] Contact: Nicole McAllister 718-920-7704 [email protected] Principal Investigator: Daniel Goldstein, MD Sub-Investigator: Simon Maybaum, MD Mount Sinai Hospital Recruiting New York, New York, United States, 10029 Contact: Anelechi Anyanwu, MD [email protected] Contact: Javier Castillo, MD 212-659-1360 [email protected] Principal Investigator: Anelechi Anyanwu, MD Principal Investigator: Sean Pinney, MD
United States, Pennsylvania University of Pittsburgh Medical Center Recruiting Pittsburgh, Pennsylvania, United States, 15213 Contact: Robert Kormos, MD [email protected] Contact: Jennifer Gabany, MSN, CRNP-C, CCRC 412-648-6362 [email protected] Principal Investigator: Robert Kormos, MD Sub-Investigator: Michael Siegenthaler, MD Allegheny General Hospital Recruiting Pittsburgh, Pennsylvania, United States, 15212 Contact: Srinivas Murali, MD [email protected] Contact: Sherri Stutz 412-359-3878 [email protected] Sub-Investigator: Srinivas Murali, MD Principal Investigator: Stephen Bailey, MD
United States, Utah University of Utah Recruiting Salt Lake City, Utah, United States, 84132 Contact: Arun Singhal, MD 801-581-5311 [email protected] Contact: Erin Davis, RN [email protected] Principal Investigator: Arun Singhal, MD Sub-Investigator: Edward Gilbert, MD
United States, Washington Sacred Heart Medical Center Recruiting Spokane, Washington, United States, 99204 Contact: Tim Icenogle, MD 509-590-9414 [email protected] Contact: Mark Puhlman, ARNP, MSN 509-474-7163 [email protected] Principal Investigator: Tim Icenogle, MD Sub-Investigator: John Everett, MD
United States, Wisconsin St. Luke's Medical Center Recruiting Milwaukee, Wisconsin, United States, 53215 Contact: Alfred Tector, MD 414-649-3780 [email protected] Contact: Cheryl Zywicki, RN, CCRP 414-385-2474 [email protected] Principal Investigator: Alfred Tector, MD
Sponsors and Collaborators
Ventracor
International Center for Health Outcomes and Innovation Research
More Information
Study ID Numbers: CLP 12082 First Received: June 20, 2007 Last Updated: January 13, 2008 ClinicalTrials.gov Identifier: NCT00490321 Health Authority: United States: Food and Drug Administration
Keywords provided by Ventracor: VentrAssistTM LVAD End-stage heart failure Cardiomyopathy
Study placed in the following topic categories: Heart Diseases Cardiomyopathies Heart Failure, Congestive
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