Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524862
Status:
TERMINATED
Last Update Posted:
2015-07-31
First Post:
2007-08-29
Brief Title:
Standard Drug Therapy vs Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-ICD
Brief Summary:
Recent ACCAHAESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF 40 Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF 30 Class I recommendation There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 This study will randomize patients with CHD and an EF between 30 and 40 to ICD therapy vs No ICD therapy The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1 greater absolute yearly increase than patients receiving an ICD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None