CentriMag Failure-to-Wean Post Approval Study

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Healt Medical Center, Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CentriMag Circulatory Support System

Device

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.

Primary outcomes

Survival to 30 days Post CentriMag support or to hospital discharge

Time frame: 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

Time frame: Approximately 30 days

The proportion of subjects who do not recover and are bridged to a transplant or long-term system

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

CentriMag Failure-to-Wean Post-Approval Study

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Jul 9, 2020
Registry last updated: Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed