NCT04464785

CentriMag Failure-to-Wean Post Approval Study

CentriMag Failure-to-Wean Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-30
• Primary completion: 2024-10-25
• Completion: 2024-10-25
• First posted: 2020-07-09
• Last updated: 2024-12-11

Locations

8 sites across 1 country: United States