A Medical Device Daily

Medtronic (Minneapolis), along with partners, reported details of several major clinical trials aimed at developing and validating new and innovative risk stratification tools to predict which post-myocardial infarction (MI) patients are at greatest risk of Sudden Cardiac Arrest (SCA).

"We are on the cusp of new discoveries in clinical cardiology. These trials will utilize advanced innovations in technology and research, spanning novel diagnostics to genomics," said David Steinhaus, MD, vice president and medical director of the Cardiac Rhythm Disease Management business at Medtronic.

• 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 sudden cardiac arrest risk, followed by an observational cohort study to develop and validate a tool to determine which patients will benefit most from an 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%. 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. 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 part of a National Institutes of Health (NIH) 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.

• The objective of Medtronic's GAME (Genetic Arrhythmia Markers for Early Detection) trial is to determine if genetic markers can be used to identify individuals with an increased susceptibility to SCA. Involving 1,000 patients at more than 30 sites in the 48 contiguous U.S., GAME will study cardiac events retrospectively to potentially develop a genetic risk scoring system to determine which patients would benefit from an ICD. The first patient enrollment in GAME recently took place at Arkansas Cardiology Clinic in Little Rock, Ark.

• Also underway is the Medtronic-supported DISCOVERY (Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Ventricular Tachyarrhythmias in ICD Patients) trial, involving nearly 1,300 patients at approximately 80 centers in Europe. DISCOVERY is a non-randomized, prospective, multicenter study and is composed of two parts. The first is double-blinded and collects data on genetic polymorphisms and potential prognostic of ventricular and atrial tachyarrhythmias. The second part evaluates the influence of dual chamber ICD-based diagnostic information on long-term patient management and treatment.

In other HRS news:

• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance and European CE mark approval of new delivery tools designed to give physicians greater control and precision when placing cardiac pacing leads in challenging heart anatomy.

The CPS Duo stylet and guidewire system and the CPS Courier guidewire received FDA clearance and CE Mark approvals, and the Mond stylet received FDA clearance. The tools are designed to place leads in precise positions that, while optimal for delivering pacing therapy, can be difficult to access.

"The CPS Duo system provides a new level of control for delivering the QuickFlex and QuickSite leads to often challenging locations in the heart," said John Rogers, MD, from Scripps Clinic (La Jolla, California). "This means that I can more easily maneuver the lead to the best position for the patient."