CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Optimizer System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01381172
NCT01381172N/ACompleted
CompareCT.gov

Evaluation of the Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%: FIX-HF-5C

Impulse Dynamics·interventional·Posted Jun 27, 2011·Updated Sep 17, 2021

In Brief

A clinical study evaluating Optimizer System and No intervention: Optimal medical therapy for NYHA Class III Heart Failure and NYHA Class IV Heart Failure. Completed, enrolled 160 participants across 42 sites in 3 countries.

Detailed Summary

The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNYHA Class III Heart Failure, NYHA Class IV Heart Failure
CountriesCzechia, Germany, United States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartJan 1, 2011
Primary CompletionMar 19, 2019
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 15.0 years ago

Interventions

Optimizer Systemdevice

The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.

No intervention: Optimal medical therapyother

The control group receives optimal medical therapy only.