CentriMag Failure-to-Wean Post Approval Study
1 other identifier
observational
32
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2020
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2024
CompletedDecember 11, 2024
December 1, 2024
3.8 years
July 7, 2020
December 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Survival to 30 days Post CentriMag support or to hospital discharge
The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
30 days
Survival to induction of anesthesia for surgery for transplant or a long-term system
The proportion of subjects who do not recover and are bridged to a transplant or long-term system
Approximately 30 days
Study Arms (1)
Treatment
Subjects who receive the CentriMag Circulatory Support System
Interventions
The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.
Eligibility Criteria
Male and female subjects who fail-to-wean from cardiopulmonary bypass.
You may qualify if:
- 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
You may not qualify if:
- Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Baptist Healt Medical Center
Little Rock, Arkansas, 72205, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
University of Michigan
Ann Arbor, Michigan, 48104, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Crowe
Abbott
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 9, 2020
Study Start
December 30, 2020
Primary Completion
October 25, 2024
Study Completion
October 25, 2024
Last Updated
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share