CentriMag Failure-to-Wean Post Approval Study

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: CentriMag Circulatory Support System

Study type: Observational

Funder types: Industry

Identifiers

NCT04464785

ABT-CIP-10336

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB

Trial design

32 participants in 1 patient group

Treatment

Description:

Subjects who receive the CentriMag Circulatory Support System

Treatment:

Device: CentriMag Circulatory Support System