Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 10, 2020
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 Phase
Heart Failure Device: CentriMag Circulatory Support System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single arm, open-label, multi-center study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CentriMag Failure-to-Wean Post-Approval Study
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
Experimental: 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
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

Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Poormina Sood, MD 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: July 10, 2020
Last Verified: July 2020
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