Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-04-03 @ 2:37 PM
Study NCT ID:
NCT00111969
Status:
COMPLETED
Last Update Posted:
2006-07-04
First Post:
2005-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACCLAIM - Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy
Sponsor:
Vasogen
Organization:
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 system's physiological anti-inflammatory response. The ACCLAIM study is an international, approximately 2,000-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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: