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G. Michael Deeb, M.D.

G. Michael Deeb, M.D. - Research

  1. Medtronic Inc.
    Clinical Investigation Plan for Medtronic Heart Valve Freestyle Aortic Root Bioprosthesis Model 995 (size 29mm)
    Co-Investigator
  2. Edwards Life Sciences
    Clinical Investigation Plan for Edwards Prima Plus Stentless bioprosthesis Model 2500P
    Investigator
  3. Medtronic, Inc.
    Long Term Evaluation of the Freestyle Valve
    Investigator
  4. 4. W. L. Gore & Associates, Inc.
    Evaluation of the GORE TAG Thoracic Endoprosthesis-45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta
    Co-Investigator
  5. Bolton Medical
    A Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients with Thoracic Aortic Pathologies
    Co-Investigator

The EXPEDITION Trial (Na+/H+ EXchange Inhibition to Prevent Coronary Events in Acute Cardiac Conditions)

(A double-blind, placebo-controlled, multinational trial to investigate the effect of IV treatment with the Na+/H+ exchange inhibitor cariporide (HOE642) 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).

Investigators: Steven F. Bolling, MD, Richard L. Prager, MD, G. Michael Deeb, MD, Francis D. Pagani, MD, PhD, Surgery; and Wei C. Lau, MD, Anesthesiology.

Funding: Aventis Pharmaceutical, Inc.

Cariporide (HOE642) is a potent and selective inhibitor of the Na+/H+ exchange (NHE) subtype 1, an ion exchanger that plays a pivotal role in the setting of myocardial ischemia and reperfusion. Blocking the NHE-1 ion exchange system shuts down the initial step of the ionic exchanges in the heart which cause sodium/calcium overload and consequently cell necrosis. Cariporide is the first substance in this new class of NHE inhibitors.

The primary objective is to demonstrate that cariporide reduces the combined incidence of all-cause mortality and non-fatal MI by Day 5 compared to placebo in patients at risk of myocardial necrosis during and after CABG surgery. The secondary objective is to demonstrate that cariporide reduces the combined incidence of all-cause mortality and non-fatal MI by Day 5 compared to placebo in patients at risk of myocardial necrosis during and after CABG surgery.

The "BEST" Trial: BioGlue Surgical Adhesive Efficacy and Safety Trial as a Surgical Adjunct in the Treatment of Type A Aortic Dissection

Investigators: G. Michael Deeb, MD, Steven F. Bolling, MD, Francis D. Pagani, MD, PhD, Surgery

Funding: Cryolife, Inc.

This research focuses on patients, 18 years or older, with a confirmed diagnosis of an acute Type A aortic dissection and who, in the opinion of the investigator, require emergent surgical repair. BioGlue Surgical Adhesive is intended to be used as an adjunct in the surgical repair of acute, Type A aortic dissections. It has been proposed that application of BioGlue to the repair site will decrease early hospital discharge mortalities, compared to that of patients receiving standard surgical repair.

29mm Freestyle Valve Study

Investigators: G. Michael Deeb, MD, Steven F. Bolling, MD, Francis D. Pagani, MD, PhD, Surgery

Funding: Medtronic, Inc.

The FreeStyle valve is a stentless bioprosthesis (porcine) that is specially treated with an anti calcification agent and zero pressure fixated. The durability is hoped to be longer than the traditional porcine valves. The FreeStyle valve has been released for commercial use in sizes 19-27mm. Because the 29mm size was not used in the original clinical trial, the FDA has required specific study of this size with at least one year followup. This study is being performed at six clinical sites with enrollment up to 60 patients.

A New Aortic Root Prothesis: Outcome and Follow-Up

(Edwards Prima Plus Stentless Bioprosthesis Model 2500P)

Investigators: G. Michael Deeb, MD, Surgery; and David Bach, MD, Internal Medicine

Funding: Edwards Lifesciences LLC

The Edwards Life Science PRIMA valve is a stentless bioprosthesis valve size (21-29mm) used in the aortic position. The clinical trial was conducted in a multi-center setting. The valve has been released for market use. Long term follow-up is ongoing with the study patients.