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NCT03339310 · ClinicalTrials.gov registry record · NA
Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System
A NA study, sponsored by Impulse Dynamics.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03339310: Completed NA study, sponsored by Impulse Dynamics.
NCT03339310 is a NA study that has completed, run by Impulse Dynamics. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03339310, a NA study, has completed, sponsored by Impulse Dynamics.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads
Primary Outcome
Device efficacy will be assessed as change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX). Subjects on device under FIX-HF-5C2 protocol will be compared to subjects on control under FIX-HF-5C protocol with respect to peak V02 mean change at 24-weeks from baseline.
Interventions
- DEVICE Optimizer Smart System with 2-leads
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2019-10-30 |
| Phase | NA |
What the finished NCT03339310 record still lists
NCT03339310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Optimizer Smart System with 2-leads is the first listed.
NCT03339310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03339310 about?
NCT03339310 is a clinical study titled "Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System". This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads
What is the current status of trial NCT03339310?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2017-10-23. Estimated completion is 2019-10-30.
What interventions are being tested in trial NCT03339310?
The interventions under investigation include: Optimizer Smart System with 2-leads (DEVICE).
Who is sponsoring clinical trial NCT03339310?
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 NCT03339310's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 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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