Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111969
Status:
COMPLETED
Last Update Posted:
2006-07-04
First Post:
2005-05-26
Brief Title:
ACCLAIM - Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy
Sponsor:
Vasogen
Organization:
Vasogen
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Parallel Group Placebo-Controlled Study to Assess the Effects of the Celacade System on Mortality and Morbidity in Patients With Chronic Heart Failure
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety and efficacy of the Celacade system in reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic systolic heart failure
Detailed Description:
Evidence continues to accumulate on the importance of inflammation in the development and progression of heart failure HF The Celacade system may reduce chronic inflammation by stimulating the immune systems physiological anti-inflammatory response The ACCLAIM study is an international approximately 2000-patient Phase III clinical research study designed to test the safety and efficacy of the Celacade system in reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic systolic HF
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