Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112125
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2005-05-27
Brief Title:
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure FIX-HF-5
Sponsor:
Impulse Dynamics
Organization:
Impulse Dynamics
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of the OPTIMIZER System With Active Fixation Leads in Subjects With Heart Failure Resulting From Systolic Dysfunction FIX-HF-5
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms
Detailed Description:
IMPULSE Dynamics FIX HF 5 US Study is a prospective multi-center study to evaluate the safety and efficacy of cardiac contractility modulation CCM signals delivered by the implantable OPTIMIZER System in patients with NYHA class IIIIV heart failure The study will involve the recruitment of approximately 420 subjects at a total of up to 50 sites nationwide
Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomized to receive the OPTIMIZER System or to a control group All subjects randomized will be followed for 1 year and shall receive the same study related assessments throughout the course of the study In addition all subjects will continue to receive optimal medical therapy for the treatment of their heart failure
The primary efficacy assessment consists of a change in exercise tolerance measured by cardiopulmonary exercise testing at baseline and 6 months Safety variables such as the rate and cause of hospitalizations or death shall be collected in both groups and shall be compared at 12 months
Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomized to receive the OPTIMIZER System or to a control group All subjects randomized will be followed for 1 year and shall receive the same study related assessments throughout the course of the study In addition all subjects will continue to receive optimal medical therapy for the treatment of their heart failure
The primary efficacy assessment consists of a change in exercise tolerance measured by cardiopulmonary exercise testing at baseline and 6 months Safety variables such as the rate and cause of hospitalizations or death shall be collected in both groups and shall be compared at 12 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FIX-HF-5 | OTHER | Impulse Dynamics | None |