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NCT01381172 · ClinicalTrials.gov registry record · NA
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
A NA study, sponsored by Impulse Dynamics.
- Completed
- Registry status
- NA
- Development phase
- 160
- Enrollment target
NCT01381172: Completed NA study, sponsored by Impulse Dynamics.
NCT01381172 is a NA study that has completed, run by Impulse Dynamics. The registered enrollment target is 160 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381172, a NA study, has completed, sponsored by Impulse Dynamics.
- COMPLETED
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
Study 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.
Primary Outcome
Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX) and evaluated by a blinded core lab.
Interventions
- DEVICE Optimizer System
- OTHER No intervention: Optimal medical therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2011-01 |
| Est. Completion | 2019-03-19 |
| Phase | NA |
What the finished NCT01381172 record still lists
NCT01381172 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Optimizer System is the first listed.
NCT01381172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381172 about?
NCT01381172 is a clinical study titled "Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C". 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.
What is the current status of trial NCT01381172?
This trial is currently completed. It is a NA study. The enrollment target is 160 participants. The study started on 2011-01. Estimated completion is 2019-03-19.
What interventions are being tested in trial NCT01381172?
The interventions under investigation include: Optimizer System (DEVICE), No intervention: Optimal medical therapy (OTHER).
Who is sponsoring clinical trial NCT01381172?
This trial is sponsored by Impulse Dynamics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01381172's enrollment target sits among peer trials
160 628th of 2000 higher than 1,347 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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