What Can We Expect from the ISSUE 3 Trial?

摘要

The ISSUE 3 Trial is designed to demonstrate which patients with vasovagal syncope over the age of 40 years will benefit from pacing dual chamber with the rate drop response. The trial has completed its recruitment of 521 patients and 78 have now been randomized in Phase 2, which is the Pacing ON versus Pacing OFF comparison. During this Phase the end-points are recurrence of syncope or two years of follow-up without recurrence. It has been calculated that 27 early end-points will be sufficient to determine a significant difference between the groups. The background, details and design of the trial are explained. Some early findings are presented. Definitive results are expected by the end of 2011.