Clinical trial NCT00819793: CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
Official title: Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac Dysfunction
Failure-to-wean from CPB
CentriMag
Levitronix
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2009-01-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Survival
timeFrame: 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 outcomes:
measure: Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
timeFrame: Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital, Arizona
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Minneapolis
country: United States
facility: Fairview University Medical Center
state: Minnesota
city: New York
country: United States
facility: New York Columbia Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: St. Luke's Episcopal
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: Pooja Chatterjee
role: STUDY_DIRECTOR
References: