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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CentriMag Ventricular Assist System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Dysfunction, Failure-to-wean from CPB, CentriMag, Levitronix, Thoratec Corporation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • Mayo Clinic Hospital, Arizona
  • Yale University
  • University of Kentucky
  • University of Maryland
  • Fairview University Medical Center
  • New York Columbia Presbyterian Hospital
  • University of Rochester
  • Duke University Medical Center
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • St. Luke's Episcopal
  • Intermountain Medical Center
  • University of Utah
  • St. Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CentriMag Ventricular Assist System

Arm Description

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

Outcomes

Primary Outcome Measures

Survival
Number of patients alive 30 days after device implantation

Secondary Outcome Measures

Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP.

Full Information

First Posted
January 8, 2009
Last Updated
June 23, 2022
Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00819793
Brief Title
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
Official Title
Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Dysfunction, Failure-to-wean from CPB, CentriMag, Levitronix, Thoratec Corporation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CentriMag Ventricular Assist System
Arm Type
Experimental
Arm Description
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
Intervention Type
Device
Intervention Name(s)
CentriMag Ventricular Assist System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival
Description
Number of patients alive 30 days after device implantation
Time Frame
30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant
Secondary Outcome Measure Information:
Title
Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
Description
Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP.
Time Frame
Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: cardiac index ≤ 2.2 L/min/m2 For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Chatterjee
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Fairview University Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
New York Columbia Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
St. Luke's Episcopal
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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

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