CentriMag Failure-to-Wean Post Approval Study

Heart Failure Clinical Trial

Official title:

CentriMag Failure-to-Wean Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464785
• Other study ID #: ABT-CIP-10336
• Status: Recruiting
• Start date: December 30, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: Hua-Wen Ding, MD, PhD
• Phone: +32488151239
• Email: huawen.ding[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Baptist Healt Medical Center	Little Rock	Arkansas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	New York Presbyterian/ Columbia University Medical Center	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Advent Health Orlando	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to 30 days Post CentriMag support or to hospital discharge	The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).	30 days
Primary	Survival to induction of anesthesia for surgery for transplant or a long-term system	The proportion of subjects who do not recover and are bridged to a transplant or long-term system	Approximately 30 days