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St. Jude Medical announces PAVE and DINAMIT clinical trial results

ST. PAUL, MN, March 8, 2004 -- St. Jude Medical, Inc. (NYSE:STJ) announced today the results of the PAVE (Post AV Nodal Ablation Evaluation) and DINAMIT (Defibrillator IN Acute Myocardial Infarction Trial) clinical studies at the American College of Cardiology's (ACC) Annual Scientific Session 2004 in New Orleans, Louisiana. Both studies were sponsored by St. Jude Medical.

The data from the PAVE study indicates potential benefits of cardiac resynchronization therapy (CRT) in non-heart failure patient populations, while the data from the DINAMIT study showed no overall mortality benefit of implantable cardioverter defibrillator (ICD) therapy in patients following a recent acute myocardial infarction (heart attack).

PAVE is the first large-scale, prospectively randomized study to evaluate Biventricular (BV) pacing vs. standard Right Ventricular (RV)-only pacing in patients undergoing ablate and pace therapy for atrial fibrillation (AF). The study found that:

  • In patients with chronic AF treated with AV nodal ablation (targeted destruction of the AV node, the heart tissue that conducts the electrical impulse from the atria to the ventricles), biventricular pacing produced a statistically significant improvement in cardiac function over standard right-ventricular pacing as measured by the six minute walk test.
  • In these same patients, biventricular pacing also produced a statistically significant improvement in functional capacity over standard right-ventricular pacing as measured by peak VO2 and exercise duration.
  • BV-paced patients experienced fewer deaths during the trial than RV-paced patients.

Based on these results, the PAVE study suggests that BV pacing should be the preferred mode of pacing therapy in patients with chronic AF undergoing AV nodal ablation.

"The objective of the PAVE trial was to prospectively compare the effect of BV pacing versus RV pacing in pa
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Contact: Mechal Weiss
mechal.weiss@edelman.com
212-642-7731
Edelman Public Relations
8-Mar-2004


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