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http://209.85.173.104/search?q=cache:kaEr5ZHIntAJ:clinicaltrials.gov/ct2/show/NCT00483197%3Fspons%3D%2522Ventracor%2522%26spons_ex%3DY%26rank%3D3+Salpy+Pamboukian+ventracor&hl=en&ct=clnk&cd=4&gl=au


VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

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: NCT00483197

Purpose
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.



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, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial


Further study details as provided by Ventracor:


Primary Outcome Measures:
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.



Secondary Outcome Measures:
Quality of life

Functional status

Neurocognitive function


Estimated Enrollment: 140
Study Start Date: June 2007
Estimated Study Completion Date: June 2010

Detailed Description:
LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants.

The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.

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; more specific criteria are included in the study protocol):

Approved and listed for cardiac transplantation.
Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.
Exclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol):

Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
Presence of any mechanical circulatory support other than intra-aortic balloon pump.
Therapy with an investigational intervention at the time of screening.
Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier: NCT00483197

Contacts


Contact: Helene S Zintak 650.456.5995 [email protected]

Contact: Sherry Mathews 650-356-5960 [email protected]


Locations


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]
Principal 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 Sorensen, PhD 410-328-2737 [email protected]
Principal Investigator: Bartley Griffith, MD

United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Lyle Joyce, MD 612-625-8230 [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 212-305-0828 [email protected]
Contact: Margaret Flannery, RN 212-305-6300 [email protected]
Principal Investigator: Yoshifumi Naka, MD
Sub-Investigator: Mario Deng, 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
Sub-Investigator: Sean Pinney, 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

United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Benjamin Sun, MD 614-293-4558 [email protected]
Contact: Tammy Yanssens, BSN 614-293-8173 [email protected]
Principal Investigator: Benjamin Sun, MD
Sub-Investigator: David Feldman, MD, PhD

United States, Pennsylvania
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Robert Kormos, MD 412-648-6200 [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]
Principal Investigator: Srinivas Murali, MD
Principal Investigator: Stephen Bailey, MD
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rohinton Morris, MD [email protected]
Contact: Mary Lou O'Hara, RN 215-614-0365 [email protected]
Principal Investigator: Rohinton Morris, MD
Sub-Investigator: Michael Acker, 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 Zywicky, 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

Responsible Party: Washington Hospital/Barnes Jewish Hospital ( Nader Moazami, MD Sugical PI )
Study ID Numbers: CLP 06005-04
First Received: June 4, 2007
Last Updated: January 13, 2008
ClinicalTrials.gov Identifier: NCT00483197
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




Additional relevant MeSH terms:
Cardiovascular Diseases



ClinicalTrials.gov processed this record on January 18, 2008




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