CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 428 enrolled
Drug / intervention
OPTIMIZER Systemdevice
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age ≥18 years
  • ✓Baseline ejection fraction ≤35% by echocardiography
  • ✓Heart failure treatment for ≥90 days including β-blocker for ≥90 days (unless intolerant)
  • ✓NYHA functional Class III or IV at enrollment
Key exclusion· 12
  • ✕Baseline VO2max <9 ml O2/min/kg
  • ✕Potentially correctable cause of heart failure (valvular or congenital disease)
  • ✕Clinically significant angina pectoris (CCS score ≥II, unstable angina within 30 days, or angina/ECG changes on stress testing)
  • ✕Hospitalization for heart failure requiring inotropic support within 30 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112125
NCT00112125N/ACompleted
CompareCT.gov

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

Impulse Dynamics·interventional·Posted May 30, 2005·Updated Aug 6, 2020

In Brief

A clinical study evaluating OPTIMIZER System for Heart Failure, Congestive. Completed, enrolled 428 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2005
Enrollment StartFeb 1, 2005
Primary CompletionMar 19, 2019
TodayJul 2, 2026
Enrollment to primary: 14.1 yearsPosted 21.1 years ago

Interventions

OPTIMIZER Systemdevice