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

Sponsored by:	Levitronix
Information provided by:	Levitronix
ClinicalTrials.gov Identifier:	NCT00819793

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Levitronix CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial

Further study details as provided by Levitronix:

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 ]

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 ]

Estimated Enrollment:	30
Study Start Date:	October 2008

Arms	Assigned Interventions
CentriMag All patients meeting the patient selection criteria will be treated with the CentriMag device.	Device: CentriMag Ventricular Assist System

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 lever 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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Levitronix ( Mark Macedo, Director Clinical Affairs )
Study ID Numbers:	LXP-002
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819793 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Levitronix:

Cardiac dysfunction due to failure-to-wean from CPB

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009