Clinical trial
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With…
NCT01381172 · Impulse Dynamics, Industry · Completed
Key facts
| NCT number | NCT01381172 |
|---|---|
| Title | Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C |
| Official title | 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 |
| Acronym | FIX-HF-5C |
| Lead sponsor | Impulse Dynamics, Industry |
| Status | Completed |
| Study type | Interventional |
| Conditions | NYHA Class III Heart Failure, NYHA Class IV Heart Failure |
| Intervention type | Device, Other |
| Interventions | Optimizer System, No intervention: Optimal medical therapy |
| Enrollment | 160 |
| Start date | Jan 1, 2011 |
| Primary completion | Mar 19, 2019 |
| Completion | Mar 19, 2019 |
| First posted | Jun 27, 2011 |
| Last update posted | Sep 17, 2021 |
| Countries | Czechia, Germany, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: