Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01424722
Status:
TERMINATED
Last Update Posted:
2021-01-28
First Post:
2011-08-22
Brief Title:
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
ST Monitoring to Detect ACS Events in ICD Patients
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AnalyzeST
Brief Summary:
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 St Jude Medical ICD systems
Detailed Description:
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 Fortify Assura ST and Ellipse ST family of devices as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None