Research Interest:

Assisted circulation, minimally invasive cardiac surgery, cytokines and internal mammary artery blood flow,
and telemedicine in cardiac surgery (Internet Webcast, Robotically assisted surgery).

Clinical Studies

1987 – 1991 “Novacor Left Ventricular Assist System Clinical Trial”
Principal Investigator

1988 – 1993 “ABIOMED BVS 5000 Ventricular Assist Device Clinical
Principal Investigator – Resulted in FDA approval

1989 – 1997 “Portable Cardiopulmonary Support System Clinical Trial”
Principal Investigator

1991 – 1994 “Clinical Investigation of the Cryolife Cryopreserved
Allograft Human Heart Valve Replacement”
Principal Investigator

1991 – 1997 “ABIOMED Intra-arterial Cardiac Support System 8000
Clinical Trial”
Co-Principal Investigator

1996 – 1999 “PerFCT: Perma-Flow-CABG Trial”
Principal Investigator

1996 – 1997 Lung Volume Reduction Surgery”
Principal Investigator

1998 – 2000 “REDUCE Trial. Partial Left Ventriculectomy for Dilated
Cardiomyopathy: The Batista Operation”
Principal Investigator

1998 – 1999 “Myocardial Protection in a Beating Heart – Low Pressure
Retrograde Perfusion”
Principal Investigator

1998 – 1999 “Aorotomyoplasty for Heart Failure”

1998 – 1999 “Cardiogenesis TMR System. Adjunct to CABG
Randomized Study”
Co-Investigator - Resulted in FDA approval

1998 – 1999 “PLC TMR Study”
Co-Investigator - Resulted in FDA approval

1998 – 2000 “Clinical Outcomes in Beating Heart Surgery Using the

1999 – 2000 “Transarrest System”

1999 – 2000 “Cardeon CardeoNeural Pulmonary Bypass (CNPB)
Feasibility Study”
Principal Investigator – Resulted in randomized trial

1999 – 2001 “Lifepak 12 Biphasi Wave for Internal Defibrillation
Clinical Study”
Principal Investigator - Resulted in FDA approval

1999 – 2000 “Robotically Assisted Cardiac Surgery”

1999 – 2000 “Cytokines and Open Heart Surgery”
Principal Investigator

2001 – 2003 “Cerebral Optimization By Regionalization of the Aorta.
Cardeon TCM – Cobra Trial. A Randomized Study of Targeted Circulatory Management (TCM)” Multi-
institutional Trial”
Trial Principal Investigator and Site Principal Investigator – Submitted for FDA approval

2001 – 2002 “A Double-Blind, Placebo-Controlled, Multinational Trial to investigate the effect of IV
treatment with Na+/H+ exchange
Cariporide (HOE 642) on all-cause mortality and non-fatal myocardial infarction in patients at risk of
myocardial necrosis during and after coronary artery bypass graft (CABG) surgery – EXPEDITION TRIAL”
Principal Investigator – Submitted for FDA approval

2001 – 2002 “Clinical evaluation of the Shelhigh, Inc. No-React treated Porcine Bioprosthesis for Aortic
Valve Replacement”

2002 – 2003 “Prospective Clinical Study of the Sulzer Carbomedics CPHV OptiForm Mitral Valve”

2002 – 2003 “A Phase III Randomized, Parallel, Double-Blind, Multi-Center, Placebo-controlled Study of
the Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing
Coronary Artery Bypass Graft Surgery with Cardiopulmonary Bypass (PRIMO study)”
Co-Investigator – Submitted for FDA approval

2003 – 2003 “Double-blind, Placebo-controlled Ascending Dose Study of E5564, a Lipid A Antagonist, in
Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass”

2003 – 2003 “Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
Principal Investigator

2003 – 2003 “A Phase III, Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo
Treatment with CGT003 of Coronary Vein Grafts in Patients Undergoing Coronary Bypass Graft
Procedures (PREVENT IV)”

2003 – 2003 “Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability,
Pharmakinetics, and Effectiveness of Human Fibroblast Growth Factor-1 Administered by Intramyocardial
Injection for the Treatment of Coronary Heart Disease”

2003 – 2003 “Clinical Investigation of the Mitroflow Synergy PC Bioprosthesis for Aortic Valve

2003 – 2003 “Tissue vs. Mechanical Valves in the Mitral Position in Younger Patients (PERIMOUNT Valve)”

2003 – 2003 “Protocol for the Follow-Up of Omnicarbon Cardiac Valve Patients. General Clinical Study
with Specific Evaluation of Thromboembolic/Hemorrhage Risk”

2003 – 2003 “Clinical Protocol for a Double-Blind, Multi-Center Study of the Safety and Effectiveness of
Parecoxib/Valdecoxib and Placebo/Valdecoxib Compared to Placebo for Treatment of Post-Surgical Pain
in Patients Who Have Coronary Bypass Graft via Median Sternotomy”
Research Interest and Clinical Studies