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Cardiovascular Research Laboratory
Harrison Department of Surgical Research |
| Y. Joseph Woo, M.D. |
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Clinical Research |
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| Clinical Trials |
- NIH U01 CT Surgery Network (Acker PI, Woo Co-Investigator): Penn is one of eight cardiac surgery centers selected by
the NIH to conduct multicenter prospective randomized clinical
trials in cardiac surgery. The first three studies will
be: 1) Mitral Valve Repair vs. Mitral Valve Replacement
for Severe Mitral Regurgitation in Ischemic Cardiomyopathy;
2) CABG with Mitral Valve Repair vs. CABG Alone for Patients
with Coronary Artery Disease and Moderate Mitral Regurgitation;
and 3) Atrial Fibrillation Ablation Surgery vs. Medical
Therapy for Persistent Atrial Fibrillation.
- The RESTOR MV Clinical Trial (Woo PI): Penn is one of eight centers in the United States participating
in this randomized trial comparing the safety and effectiveness
of the Coapsys off-pump mitral valve repair device to standard
ring annuloplasty for repair of moderate-to-severe mitral
regurgitation.
- An 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 (Margulies, Woo Co-PI’s): Anginera™
is a sterile, cryopreserved, human fibroblast-based tissue
on a bioabsorbable ployglactin mesh scaffold (Vicryl™)
which promotes angiogenesis. Anginera™ will be surgically
implanted on the surface of the left ventricle of the heart
at the time of LVAD placement. When the heart is later removed
at the time of heart transplantation it will be evaluated
histologically for the presence of new vasculature.
- A Phase I Open Label Pilot Study to Evaluate
the Safety, Efficacy and Tolerability of Anginera for Adults
With Left Ventricular Dysfunction AND Reversible Myocardial
Ischemia undergoing CABG surgery (Woo PI): The
primary objective is to evaluate the safety and tolerability
of Anginera, a tissue engineered angiogenic cell sheet,
in adults with Left Ventricular Dysfunction and Reversible
Myocardial Ischemia undergoing a CABG procedure.
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| Placement of Anginera patch on
ischemic area of myocardium which is not amenable to traditional
revascularization. |
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