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CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass | Clinical Trials | Clareo Health

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CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass

Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial

NCT00819793•Abbott Medical Devices

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years of age
•Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass
•Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.
•All subjects must meet the following criteria at the time of enrollment:
•Hemodynamics:
•1. cardiac index ≤ 2.2 L/min/m2
•2. For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg
•3. For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat
•4. Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.
•Placement of an intra-aortic balloon pump has been attempted unless contraindicated
+3 more criteria

Exclusion Criteria

•BUN \> 100 mg/dl
•Creatinine \> 5 mg/dl
•Presence of any investigational mechanical circulatory support device
•Known history of liver cirrhosis or portal hypertension
•Pulmonary infarction
•Stroke, TIA or history of either condition within the last six months and/or any confirmed, existing neurologic deficits
•Active systemic infection defined as positive blood cultures, core temperature \>100.5 degrees, white blood count \> 12,500, and treatment with antimicrobials
•Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
•Other serious disease(s) limiting life expectancy

Locations (14)

Mayo Clinic Hospital, Arizona

Phoenix, Arizona, United States

Yale University

New Haven, Connecticut, United States

University of Kentucky

Lexington, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Fairview University Medical Center

Minneapolis, Minnesota, United States

New York Columbia Presbyterian Hospital

New York, New York, United States

University of Rochester

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

October 1, 2008

Primary Completion Date

May 1, 2013

Completion Date

September 1, 2013

Last Updated

June 27, 2022

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

CentriMag Ventricular Assist System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass

Inclusion Criteria

Exclusion Criteria

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