CentriMag Failure-to-Wean Post Approval Study

NCT ID: NCT04464785

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-30

Study Completion Date

2024-10-25

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Subjects who receive the CentriMag Circulatory Support System

CentriMag Circulatory Support System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Crowe

Role: STUDY_DIRECTOR

Abbott

Locations

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Baptist Healt Medical Center

Little Rock, Arkansas, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States

Site Status

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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ABT-CIP-10336

Identifier Type: -

Identifier Source: org_study_id