CentriMag Failure-to-Wean Post Approval Study

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: CentriMag Circulatory Support System

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Hua-Wen Ding, MD, PhD; Phone Number: +32488151239; Email: huawen.ding@abbott.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • Baptist Healt Medical Center
      • Contact: Karol Mudy, MD
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University Medical Center
      • Contact: William Hiesinger, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Withdrawn
      • University of Colorado
  • Florida
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Advent Health Orlando
      • Contact: Scott Silvestry, MD
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • Advocate Christ Medical Center
      • Contact: Antone Tatooles, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Recruiting
      • University of Michigan
      • Contact: Francis Pagani, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Medical Center Fairview
      • Contact: Andrew Shaffer, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Barnes Jewish Hospital
      • Contact: Muhammad Masood, MD
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • New York Presbyterian/ Columbia University Medical Center
      • Contact: Koji Takeda, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28206
      • Recruiting
      • Carolinas Medical Center
      • Contact: Eric Skipper, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of The University of Pennsylvania
      • Contact: Christian Bermudez, MD
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Contact: Craig Selzman, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Lucian Durham, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects who fail-to-wean from cardiopulmonary bypass.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Treatment; Subjects who receive the CentriMag Circulatory Support System

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Sara Ahmed, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ABT-CIP-10336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No