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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 is a NA study that was terminated before completion, run by Nuwellis. The registered enrollment target is 38 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01740596
The ClinicalTrials.gov registry entry for NCT01740596 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nuwellis, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which C-Pulse® System Counterpulsation is the first listed.
NCT01740596 reports 0 study locations.
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.
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