Congestive Heart FailureNCT01471795
The Epidemiology of Ventricular Assist Device-Related Infections
An observational study of Congestive Heart Failure, run by Icahn School of Medicine at Mount Sinai at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 150 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2006to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage heart failure who demonstrate the need for intermediate or long-term support with a VAD.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Jewish Hospital
Louisville, Kentucky, 40202
University of Wisconsin Hospital
Madison, Wisconsin, 53792
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia Presbyterian Medical Center
New York, New York, 10032
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
LDS Hospital
Salt Lake City, Utah, 84143
Sharp Memorial Hospital
San Diego, California, 92123
Sacred Heart Medical Center
Spokane, Washington, 99204
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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.
Read the detailed description
Infections are one of the most serious of ventricular assist device (VAD) related complications. Many of these infections are associated with significant patient morbidity and mortality. Diagnosis of these infections is often difficult due to the complicated nature of the patient's medical problems, the need for rapid institution of empiric antibiotic therapy and the lack of established criteria that define infection. Staphylococci are among the most common causes of VAD infections. The basis for this high incidence is not well understood but is believed to be in part due to inoculation of staphylococcal commensal flora into wound sites at the time of surgery or thereafter. The goals of this observational study are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD related infection.
This is a prospective, multi-center, observational study to identify risk factors associated with the development of VAD-related infections. Patients will be followed for up to one year following VAD implantation, time of death or transplantation, whichever comes first. There will be no randomization for this observational study.
- Conditions
- Congestive Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Bacteria normally live on our skin and in our noses.After surgery, they can infect the VAD. We will collect cultures before and after surgery and compare these bacteria to bacteria that cause infections.Their genes will be compared to see which ones help the bacteria cause infection. We hope this will help develop new ways to help prevent VAD infections.
Measured: 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
Information will be collected on patient's medical condition after surgery including blood tests to help determine if an infection is present.
Measured: Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Costs (direct)
The value of all resources that are consumed in the provision of an intervention or dealing with the side-effects or other current and future consequences linked to it.
Measured: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Adverse Events
Since this is an observational study there will be no adverse events directly attributable to a study intervention. However, adverse events that might potentially contribute to the risk or course of VAD-related infections will be monitored.
Measured: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Patrice Desvigne-Nickens, Study director, National Heart, Lung, and Blood Institute (NHLBI)Yoshifumi Naka, MD, Study chair, Columbia UniversityMichael Parides, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471795
- Sponsor's protocol ID
- 08-1093 HP
- Other IDs
- 5P50HL077096
- Status last verified
- Nov 2011
- First submitted
- 7 Nov 2011
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23315371Gordon 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.
PubMed 22457291
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology of Ventricular Assist Device-Related Infections
- ClinicalTrials.gov ID
- NCT01471795
- Acronym / sponsor ID
- 08-1093 HP
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infections are one of the most serious of ventricular assist device (VAD) related complications. Many of these infections are associated with significant patient morbidity and mortality. Diagnosis of these infections is often difficult due to the complicated nature of the patient's medical problems, the need for rapid institution of empiric antibiotic therapy and the lack of established criteria that define infection. Staphylococci are among the most common causes of VAD infections. The basis for this high incidence is not well understood but is believed to be in part due to inoculation of staphylococcal commensal flora into wound sites at the time of surgery or thereafter. The goals of this observational study are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD related infection.
This is a prospective, multi-center, observational study to identify risk factors associated with the development of VAD-related infections. Patients will be followed for up to one year following VAD implantation, time of death or transplantation, whichever comes first. There will be no randomization for this observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage heart failure who demonstrate the need for intermediate or long-term support with a VAD.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of suspected infections, characterized by infecting organism and location.
Time frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
The primary goal is to collect information that describes infections in patients receiving LVADs.
4 secondary outcomes
Collect and quantify culture results for suspected infections and the secondary manifestations of infection
Time frame: 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
Time frame: Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Costs (direct)
Time frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Adverse Events
Time frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
- Derived from this study: PubMed 23315371Gordon 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.
- Derived from this study: PubMed 22457291Gordon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Desvigne-Nickens study director
National Heart, Lung, and Blood Institute (NHLBI)
Yoshifumi Naka, MD study chair
Columbia University
Michael Parides, PhD principal investigator
Icahn School of Medicine at Mount Sinai
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Icahn School of Medicine at Mount Sinai at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of suspected infections, characterized by infecting organism and location. (time frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.