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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: CentriMag Ventricular Assist System

• Registration Number: NCT00819793
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2013-05
• Study Completion: 2013-09
• Disposition First Submitted: 2014-05-30
• Disposition First Submitted QC: 2014-10-30
• Disposition First Posted: 2014-11-06
• Results First Submitted: 2017-12-19
• Results First Submitted QC: 2019-01-28
• Results First Posted: 2019-02-19
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CentriMag Ventricular Assist System	CentriMag Ventricular Assist System	All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.

Primary Outcome Measures

Name	Time	Method
Survival	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 Outcome Measures

Name	Time	Method
Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)	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.

Trial Locations

Locations (14)

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Fairview University Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

New York Columbia Presbyterian Hospital; 🇺🇸 New York, New York, United States

Mayo Clinic Hospital, Arizona; 🇺🇸 Phoenix, Arizona, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

St. Luke's Episcopal; 🇺🇸 Houston, Texas, United States

St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States