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Completed

NCT Number: NCT00819793

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Hospital, Arizona, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CentriMag Ventricular Assist System

Device

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 outcomes

  1. 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

    Number of patients alive 30 days after device implantation

Secondary outcomes

  1. Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)

    Time frame: Mean CVP or MAP during support (up to 30 days) minus baseline CVP or 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Thoratec Corporation

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2009
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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