NCT04464785Completed
CentriMag Failure-to-Wean Post Approval Study
CentriMag Failure-to-Wean Post-Approval Study
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
The primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 32 (actual)
- First submitted
- 7 Jul 2020
- Start date
- 30 Dec 2020
- Primary completion date
- 25 Oct 2024
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Heart failure
- NCT number
- NCT04464785
What you commit to
- Study type: Observational
- Participants enrolled: 32
- From 30 Dec 2020 to the primary completion date, 25 Oct 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Who the study is looking for
- Subject \>18 years of age
- Subject or legal representative has signed Informed Consent Form (ICF)
- Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from Cardiopulmonary Bypass
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Baptist Healt Medical Center Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of Minnesota Medical Center, Fairview Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Advocate Christ Medical Center Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.