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

NCT00819793 | Completed Results DMC

• 1 other identifier: LXP-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 14

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.

Conditions

Heart Failure

Keywords

Cardiac Dysfunction; Failure-to-wean from CPB; CentriMag; Levitronix; Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• Survival

  Number of patients alive 30 days after device implantation

  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 (1)

• 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

Study Arms (1)

CentriMag Ventricular Assist System

EXPERIMENTAL

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

Device: CentriMag Ventricular Assist System

Interventions

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.

CentriMag Ventricular Assist System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Thoratec Corporation: collaborator

Study Sites (14)

Mayo Clinic Hospital, Arizona

Phoenix, Arizona, 85054, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Fairview University Medical Center

Minneapolis, Minnesota, 55455, United States

Location

New York Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Luke's Episcopal

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Poornima Sood
• Organization: Abbott

psood@sjm.com

Study Officials

• Pooja Chatterjee

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 27, 2022
• Results First Posted: February 19, 2019

Record last verified: 2022-06

Locations

US (14)