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

NCT ID: NCT00819793

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-09-30

Brief 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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CentriMag Ventricular Assist System

All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.

Group Type: EXPERIMENTAL

CentriMag Ventricular Assist System

Intervention Type: DEVICE

All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.

Interventions

CentriMag Ventricular Assist System

All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.

Intervention Type: DEVICE

Eligibility Criteria

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
• All possible measures have been attempted to correct low arterial pH, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, dysrhythmias and residual hypothermia
• Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted
• Written, signed, and dated informed consent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thoratec Corporation

INDUSTRY

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pooja Chatterjee

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

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

St. Luke's Episcopal

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah

Salt Lake City, Utah, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

LXP-002

Identifier Type: -

Identifier Source: org_study_id