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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: October 30, 2014
Last verified: October 2014

January 8, 2009
October 30, 2014
October 2008
May 2013   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00819793 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
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.
Experimental: CentriMag Ventricular Assist System
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
Intervention: Device: CentriMag Ventricular Assist System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00819793
LXP-002
Yes
Thoratec Corporation
Thoratec Corporation
Not Provided
Study Director: Mark Macedo, RN Thoratec Corporation
Thoratec Corporation
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP