Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8 participants
OBSERVATIONAL
2013-06-30
2018-09-28
Brief Summary
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Detailed Description
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In the subjects undergoing orthotopic heart transplant (n=20), failed myocardial tissue samples will be collected from the diseased heart.
For subjects undergoing left ventricular assist device implantation (n=60), small samples will be collected from the apex core (that would be routinely discarded at the time of the implantation procedure).
For heart transplant subjects undergoing clinically indicated right heart biopsy (n=20), the collection of multiple samples including, excess myocardial biopsy samples that will not be utilized by pathology.
For subjects undergoing any heart surgery (n=80), the collection of left atrial appendages that are routinely removed to prevent thrombosis during atrial fibrillation surgery and a piece of the right atria will be cut in order to implant the cannula.
In addition, a collection of 20ml (about one tablespoon) of blood will be taken from all subjects to analyze progenitor/inflammatory cells and inflammation cytokines and pertinent medical history.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Heart failure or coronary disease
This group will have small samples collected from the apex core (that would be routinely discarded at the time of the implantation procedure) by undergoing a left ventricular assist device implantation. In addition, a blood sample will be collected.
Heart failure or coronary disease
Small samples collected from the apex core in the heart. In addition, blood samples will be taken.
Blood Draw
All subjects will have 20 ml of blood drawn for further analysis.
Heart transplant patients
This group will have multiple samples collected including, excess myocardial biopsy samples that will not be utilized by pathology. In addition, a blood sample will be collected.
Heart transplant patients
Heart samples collected including, excess myocardial biopsy samples. In addition, blood samples will be taken.
Blood Draw
All subjects will have 20 ml of blood drawn for further analysis.
Orthotopic Heart Transplant Patients
This group will have myocardial tissue samples collected from the diseased heart. In addition, a blood sample will be taken.
Orthotopic Heart Transplant Patients
Myocardial tissue samples collected from the diseased heart. In addition, blood samples will be taken.
Blood Draw
All subjects will have 20 ml of blood drawn for further analysis.
Heart Surgery Patients
This groups will have samples collected from the left atrial appendages that are routinely removed to prevent thrombosis during atrial fibrillation surgery and a piece of the right atria will be cut in order to implant the cannula. In addition, a blood sample will be taken.
Heart Surgery Patients
Heart samples will be collected from the left atrial appendages. In addition, blood samples will be taken.
Blood Draw
All subjects will have 20 ml of blood drawn for further analysis.
Interventions
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Heart failure or coronary disease
Small samples collected from the apex core in the heart. In addition, blood samples will be taken.
Heart transplant patients
Heart samples collected including, excess myocardial biopsy samples. In addition, blood samples will be taken.
Orthotopic Heart Transplant Patients
Myocardial tissue samples collected from the diseased heart. In addition, blood samples will be taken.
Heart Surgery Patients
Heart samples will be collected from the left atrial appendages. In addition, blood samples will be taken.
Blood Draw
All subjects will have 20 ml of blood drawn for further analysis.
Eligibility Criteria
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Inclusion Criteria
* left ventricular assist device implantation
* heart surgery required for atrial fibrillation and right atria cannulation
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Carl J Pepine, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Yanfei Qi
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201300122-N
Identifier Type: -
Identifier Source: org_study_id
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