CentriMag Failure-to-Wean Post Approval Study

Completed

• Conditions: Heart Failure
• Interventions: Device: CentriMag Circulatory Support System

• Registration Number: NCT04464785
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-09
• Study Start: 2020-12-30
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	CentriMag Circulatory Support System	Subjects who receive the CentriMag Circulatory Support System

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Baptist Healt Medical Center; 🇺🇸 Little Rock, Arkansas, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Minnesota Medical Center Fairview; 🇺🇸 Minneapolis, Minnesota, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States