CentriMag Failure-to-Wean Post Approval Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Treatment Subjects who receive the CentriMag Circulatory Support System |
Device: CentriMag Circulatory Support System
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.
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Outcome Measures
Primary Outcome Measures
- Survival to 30 days Post CentriMag support or to hospital discharge [30 days]
The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
- Survival to induction of anesthesia for surgery for transplant or a long-term system [Approximately 30 days]
The proportion of subjects who do not recover and are bridged to a transplant or long-term system
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject >18 years of age
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Subject or legal representative has signed Informed Consent Form (ICF)
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Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from Cardiopulmonary Bypass
Exclusion Criteria:
- None
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Baptist Healt Medical Center | Little Rock | Arkansas | United States | 72205 |
2 | Stanford University Medical Center | Palo Alto | California | United States | 94304 |
3 | University of Colorado | Aurora | Colorado | United States | 80045 |
4 | Advent Health Orlando | Orlando | Florida | United States | 32803 |
5 | Advocate Christ Medical Center | Oak Lawn | Illinois | United States | 60453 |
6 | University of Michigan | Ann Arbor | Michigan | United States | 48104 |
7 | University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | United States | 55455 |
8 | Barnes Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
9 | New York Presbyterian/ Columbia University Medical Center | New York | New York | United States | 10032 |
10 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28206 |
11 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
12 | University of Utah | Salt Lake City | Utah | United States | 84132 |
13 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Sara Ahmed, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABT-CIP-10336