Medtronic reveals details of multi-vendor, NIH study on SCA and ICDs

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During the 2008 Heart Rhythm Society (HRS) meeting last week in San Francisco, Medtronic, along with several partners, released details of several clinical trials aimed at developing and validating new and innovative risk stratification tools to predict which post-MI patients are at greatest risk of sudden cardiac arrest (SCA).

VEST/PREDICTS (The Vest Prevention of Early Sudden Death Trial/The Prediction of ICD Therapies Study) is a multicenter, randomized controlled trial designed to test a strategy to reduce the early post-MI SCA risk, followed by an observational cohort study to develop and validate a tool to determine which patients will benefit from an implantable cardioverter defibrillator (ICD) two months post-MI.

The VEST portion of the study will test the hypothesis that a non-invasive, wearable automatic defibrillator vest will reduce overall mortality in the first 60 days following an MI in patients with LVEF ≤35 percent, according to the Minneapolis-based Medtronic. The PREDICTS portion of the study aims to develop and validate a tool that predicts the occurrence of spontaneous treatable ventricular arrhythmias up to five years post-MI, and identify high-risk patients in whom an ICD would be most cost-effective.

The company said that study participants will receive either an ICD or Medtronic Reveal DX insertable cardiac monitor (ICM) to ascertain data on ICD-treatable arrhythmic events.

VEST/PREDICTS is partly funded by a National Institutes of Health grant awarded to the University of California, San Francisco (UCSF), and is co-funded by Medtronic, GE Healthcare and Zoll. It will involve up to 60 centers and more than 4,500 patients in the U.S., Canada and Europe, Medtronic said.

“The VEST/PREDICTS study is intended to address the two key deficiencies in our current post-MI treatment strategy, which include the untreated high sudden death rate in the early post-MI period and the non-specific nature of ejection fraction to predict spontaneous ventricular arrhythmias and ICD shocks,” said Jeff Olgin, MD, principal investigator for VEST/PREDICTS, and chief of cardiac electrophysiology at UCSF. “This important study will define a clear pathway to identify those patients who benefit most from ICDs.”