ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients (AnalyzeST)
This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST ICD system (or other Implantable Cardioverter Defibrillator (ICD) systems with the ST Monitoring Feature).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||ST Monitoring to Detect ACS Events in ICD Patients|
- Percent of patients who experience a false positive ST detection in 12 months FU [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: ST Monitoring Feature||
Device: Fortify ST
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Other Name: ST Monitoring Feature
This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST ICD system (or other ICD systems with the ST Monitoring Feature). Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.
|Contact: Jemymah Morley, BS||818-493-2821|
|Contact: Taraneh Farazi, PhD||8184933821|
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|Principal Investigator:||Michael Gibson, MD||Boston Clinical Research Institute|