Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CentriMag Failure-to-Wean Post Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464785
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Heart Failure Device: CentriMag Circulatory Support System

Layout table for study information
Study Type : Observational
Estimated Enrollment : 32 participants
Official Title: CentriMag Failure-to-Wean Post-Approval Study
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 31, 2025

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.




Primary Outcome Measures :
  1. 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).

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects who fail-to-wean from cardiopulmonary bypass.
Criteria

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:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464785


Contacts
Layout table for location contacts
Contact: Jody C Oyama, DrPH 971-329-5422 jody.oyama@Abbott.com

Locations
Layout table for location information
United States, Arkansas
Baptist Healt Medical Center Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: William Hiesinger, MD         
United States, Colorado
University of Colorado Withdrawn
Aurora, Colorado, United States, 80045
United States, Florida
Advent Health Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Scott Silvestry, MD         
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Antone Tatooles, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Francis Pagani, MD         
United States, Minnesota
University of Minnesota Medical Center Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Andrew Shaffer, MD         
United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Muhammad Masood, MD         
United States, New York
New York Presbyterian/ Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Koji Takeda, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28206
Contact: Eric Skipper, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christian Bermudez, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Craig Selzman, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lucian Durham, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Sara Ahmed Abbott
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04464785    
Other Study ID Numbers: ABT-CIP-10336
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases