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NCT01740596 · ClinicalTrials.gov registry record · NA
C-Pulse® System: A Heart Assist Device Clinical Study
A NA study, sponsored by Nuwellis.
- Terminated
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT01740596: Clinical Trial NA study, sponsored by Nuwellis.
NCT01740596 is a NA study that was terminated before completion, run by Nuwellis. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01740596, a NA study, was terminated before completion, sponsored by Nuwellis.
- TERMINATED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse"). The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the device in the United States.
Primary Outcome
The primary safety endpoint is serious procedure and device related adverse events as determined by CEC adjudication. No formal statistical hypotheses.
Interventions
- DEVICE C-Pulse® System Counterpulsation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-09-12 |
| Est. Completion | 2018-10-26 |
| Phase | NA |
Why NCT01740596 stopped before completion
NCT01740596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which C-Pulse® System Counterpulsation is the first listed.
NCT01740596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01740596 about?
NCT01740596 is a clinical study titled "C-Pulse® System: A Heart Assist Device Clinical Study". Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse"). The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients in moderate to severe heart failure (HF) has demonstra...
What is the current status of trial NCT01740596?
This trial is currently terminated. It is a NA study. The enrollment target is 38 participants. The study started on 2012-09-12. Estimated completion is 2018-10-26.
What interventions are being tested in trial NCT01740596?
The interventions under investigation include: C-Pulse® System Counterpulsation (DEVICE).
Who is sponsoring clinical trial NCT01740596?
This trial is sponsored by Nuwellis, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01740596's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 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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