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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT00819793
First received: January 8, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Heart Failure
Device: CentriMag Ventricular Assist System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial

Resource links provided by NLM:


Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Survival [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in hemodynamics and measures of end-organ function [ 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2008
Study Completion Date: September 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CentriMag
All patients meeting the patient selection criteria will be treated with the CentriMag device.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819793

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

No publications provided

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT00819793     History of Changes
Other Study ID Numbers: LXP-002
Study First Received: January 8, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thoratec Corporation:
Cardiac Dysfunction
Failure-to-wean from CPB
CentriMag
Levitronix

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014