The Epidemiology of Ventricular Assist Device-Related Infections
2 other identifiers
observational
150
1 country
13
Brief Summary
Infections often occur after ventricular assist devices (VADs) are placed. These infections can be very serious. The goal of this study is to understand why these infections occur. Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect the VAD. The investigators will collect cultures of your skin and nose before and after surgery. The investigators will compare these bacteria to bacteria that cause infections. Their genes will be compared to see which ones help the bacteria cause infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2006
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedNovember 16, 2011
November 1, 2011
3 years
November 7, 2011
November 15, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of suspected infections, characterized by infecting organism and location.
The primary goal is to collect information that describes infections in patients receiving LVADs.
Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Secondary Outcomes (4)
Collect and quantify culture results for suspected infections and the secondary manifestations of infection
Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Develop Guidelines to properly diagnose VAD infections
Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Costs (direct)
Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Adverse Events
Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Study Arms (1)
Study Population
150 subjects with end-stage heart failure who have been scheduled to undergo device implantation with a VAD, either as a bridge to cardiac transplantation or for destination therapy.
Eligibility Criteria
Patients with end-stage heart failure who demonstrate the need for intermediate or long-term support with a VAD.
You may qualify if:
- Age greater than or equal to 18 years.
- Approved by the institution's heart failure/transplant committee for VAD implantation, either as a bridge to cardiac transplantation or for destination therapy for end-stage heart failure.
- Signed informed consent, release of medical information, and HIPAA forms.
- Expectation of compliance with protocol procedures and study visit schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (2)
Gordon RJ, Weinberg AD, Pagani FD, Slaughter MS, Pappas PS, Naka Y, Goldstein DJ, Dembitsky WP, Giacalone JC, Ferrante J, Ascheim DD, Moskowitz AJ, Rose EA, Gelijns AC, Lowy FD; Ventricular Assist Device Infection Study Group. Prospective, multicenter study of ventricular assist device infections. Circulation. 2013 Feb 12;127(6):691-702. doi: 10.1161/CIRCULATIONAHA.112.128132. Epub 2013 Jan 11.
PMID: 23315371DERIVEDGordon RJ, Miragaia M, Weinberg AD, Lee CJ, Rolo J, Giacalone JC, Slaughter MS, Pappas P, Naka Y, Tector AJ, de Lencastre H, Lowy FD. Staphylococcus epidermidis colonization is highly clonal across US cardiac centers. J Infect Dis. 2012 May 1;205(9):1391-8. doi: 10.1093/infdis/jis218. Epub 2012 Mar 29.
PMID: 22457291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patrice Desvigne-Nickens
National Heart, Lung, and Blood Institute (NHLBI)
- STUDY CHAIR
Yoshifumi Naka, MD
Columbia University
- PRINCIPAL INVESTIGATOR
Michael Parides, PhD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 16, 2011
Study Start
January 1, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
November 16, 2011
Record last verified: 2011-11