us research grants, page-4

I think this is one of them DMA,
Salpy Pamboukian, MD gets a mention in here.

http://209.85.173.104/search?q=cache:WHklX66Rc64J:clinicaltrials.gov/ct2/show/NCT00490321%3Fspons%3D%2522Ventracor%2522%26spons_ex%3DY%26rank%3D1+Salpy+Pamboukian+ventracor&hl=en&ct=clnk&cd=3&gl=au


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

Contacts


Contact: Helene 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]
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




Additional relevant MeSH terms:
Cardiovascular Diseases



ClinicalTrials.gov processed this record on January 18, 2008



Cheers M