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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: CentriMag Ventricular Assist System

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital, Arizona
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Fairview University Medical Center
  • New York
    • New York, New York, United States, 10032
      • New York Columbia Presbyterian Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Number of patients alive 30 days after device implantation	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Thoratec Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 8, 2009
• First Submitted That Met QC Criteria: January 8, 2009
• First Posted (Estimate): January 9, 2009

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Thoratec Corporation; Cardiac Dysfunction; Failure-to-wean from CPB; CentriMag; Levitronix
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LXP-002