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NCT03102437 · ClinicalTrials.gov registry record · NA
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
A NA study, sponsored by Impulse Dynamics.
- Terminated
- Registry status
- NA
- Development phase
- 106
- Enrollment target
NCT03102437: Clinical Trial NA study, sponsored by Impulse Dynamics.
NCT03102437 is a NA study that was terminated before completion, run by Impulse Dynamics. The registered enrollment target is 106 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03102437, a NA study, was terminated before completion, sponsored by Impulse Dynamics.
- TERMINATED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
Study Summary
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
Primary Outcome
The FIX-HF-5CA Study was unofficially intended to serve as the Post-Approval Study (PAS) with the intention of collecting 3 year observed mortality data and comparing that to the predicted probability of mortality derived from two validated heart failure models \[MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and SHFM (Seattle Heart Failure Model)\]. The objective was to show that the observed prevalence of mortality was not worse than the derived predicted probability of mortality
Interventions
- DEVICE Optimizer Smart System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2019-12-16 |
| Phase | NA |
Why NCT03102437 stopped before completion
NCT03102437 is an interventional study that assigns participants to a tested intervention. The registered 106 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 (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Optimizer Smart System is the first listed.
NCT03102437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03102437 about?
NCT03102437 is a clinical study titled "Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System". This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
What is the current status of trial NCT03102437?
This trial is currently terminated. It is a NA study. The enrollment target is 106 participants. The study started on 2017-07-01. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT03102437?
The interventions under investigation include: Optimizer Smart System (DEVICE).
Who is sponsoring clinical trial NCT03102437?
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 NCT03102437's enrollment target sits among peer trials
106 830th of 2000 higher than 1,167 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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