Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
This trial is active, not recruiting.
|Treatment||anginera, a human tissue replacement therapy|
|Start date||December 2006|
|End date||November 2008|
|Trial size||15 participants|
|Trial identifier||NCT00364598, TI-102|
The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function. Patients who will have a left ventricular assist device (LVAD) implanted while they wait for a donated heart will be treated with Anginera. At the time of heart transplant, their diseased heart which is removed will be analyzed by microscopic examination to see what effect Anginera had.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|New Haven, CT||Yale University School of Medicine||no longer recruiting|
|Baltimore, MD||University of Maryland School of Medicine||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania School of Medicine||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
To analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.
Male or female participants at least 18 years old.
Inclusion Criteria: - Stage D Heart Failure - Patients having an LVAD implanted as a bridge to transplant. Exclusion Criteria: - Biopsy proven acute myocarditis - Known Giant Cell Myocarditis - Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease
|Official title||A Phase I Open Label Pilot Study to Obtain Tissue for Histological Analysis After Application of Anginera™ in Adults With A Left Ventricular Assist Device As A Bridge To Transplant|
|Principal investigator||Kenneth B Margulies, M.D.|
|Description||This will be a prospective, multi-center, randomized, open-label, within-patient paired design study. The primary purpose is to analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.|
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