C-Pulse® System: A Heart Assist Device Clinical Study
Public ClinicalTrials.gov record NCT01740596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
C-Pulse Heart Assist Device pivOtal stUdy treatiNg paTients With modERate to Severe Heart Failure C-Pulse® System: A Heart Assist Device Pivotal IDE Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01740596
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2012 (Actual)
- Primary completion
- Sep 19, 2018 (Actual)
- Completion
- Oct 26, 2018 (Actual)
- Last update posted
- Jan 11, 2024
2012 – 2018
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35249 | — |
| University of Southern California Keck School of Medicine | Los Angeles | California | 90033 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| University of Miami Medical Center | Miami | Florida | 33136 | — |
| Medical Center of Central Georgia | Macon | Georgia | 31201 | — |
| University of Louisville - Jewish Hospital | Louisville | Kentucky | 40202 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Mid America Heart Institute-Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | — |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Cornell University, New York - Presbyterian Hospital | New York | New York | 10065 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
| Charlotte-Mecklenburg Hospital - Carolinas Health Care System | Charlotte | North Carolina | 28203 | — |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Allegheny-Singer Research Institute - Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Dallas VA Medical Center | Dallas | Texas | 75216 | — |
| Texas Heart Institute - St Luke's Hospital | Houston | Texas | 77030 | — |
| VCU Medical Center | Richmond | Virginia | 23298 | — |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01740596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01740596 live on ClinicalTrials.gov.