CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
This study is currently recruiting participants.
Verified May 2013 by Thoratec Corporation
Sponsor:
Thoratec Corporation
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT00819793
First received: January 8, 2009
Last updated: May 14, 2013
Last verified: May 2013
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial |
Resource links provided by NLM:
Further study details as provided by Thoratec Corporation:
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CentriMag
All patients meeting the patient selection criteria will be treated with the CentriMag device.
|
Device: CentriMag Ventricular Assist System
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.
|
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819793
Contacts
| Contact: Mark Macedo, RN | 781-272-0139 ext 2925 | mmacedo@thoratec.com |
Locations
| United States, Arizona | |
| Mayo Clinic Hospital, Arizona | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Andre Watkins watkins.andre@mayo.edu | |
| Principal Investigator: Octavio Pajaro, MD | |
| United States, Connecticut | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Lynn Wilson lynn.wilson@ynhh.org | |
| Principal Investigator: Abeel Mangi, MD | |
| United States, Kentucky | |
| University of Kentucky | Completed |
| Lexington, Kentucky, United States, 40536 | |
| University of Louisville | Withdrawn |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Dana Beach dbeach2@smail.umaryland.edu | |
| Principal Investigator: Bartley Griffith, MD | |
| United States, Minnesota | |
| Fairview University Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Carol Toninato ctoninato@umphysicians.umn.edu | |
| Principal Investigator: Ranjit John, MD | |
| United States, New York | |
| New York Columbia Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Kathy Idrissi kc286@columbia.edu | |
| Principal Investigator: Yoshifumi Naka, MD | |
| University of Rochester | Completed |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Han Billard han.billard@duke.edu | |
| Principal Investigator: Carmelo Milano, MD | |
| United States, Ohio | |
| Ohio State University | Withdrawn |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jessica Howard jessica.howard@uphs.upenn.edu | |
| Principal Investigator: Michael Acker, MD | |
| Temple University Hospital | Withdrawn |
| Philadelphia, Pennsylvania, United States, 19140 | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Lisa Hoff hofflk2@upmc.edu | |
| Principal Investigator: Robert Kormos, MD | |
| United States, Texas | |
| Baylor University Medical Center | Withdrawn |
| Houston, Texas, United States, 77030 | |
| St. Luke's Episcopal | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Felicia Frank ffrank@heart.thi.tmc.edu | |
| Principal Investigator: William Cohn, MD | |
| United States, Utah | |
| Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84107 | |
| Contact: Marsha Eidson marsha.eidson@imail.org | |
| Principal Investigator: Steven Clayson, MD | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: erin Davis erin.davis@hsc.utah.edu | |
| Principal Investigator: Craig Selzman, MD | |
| United States, Wisconsin | |
| St. Luke's Medical Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Maggie Miller maggie.miller@aurora.org | |
| Principal Investigator: Francis Downey, MD | |
Sponsors and Collaborators
Thoratec Corporation
Investigators
| Study Director: | Mark Macedo, RN | Thoratec Corporation |
More Information
No publications provided
| Responsible Party: | Thoratec Corporation |
| ClinicalTrials.gov Identifier: | NCT00819793 History of Changes |
| Other Study ID Numbers: | LXP-002 |
| Study First Received: | January 8, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Thoratec Corporation:
|
Cardiac Dysfunction Failure-to-wean from CPB CentriMag Levitronix |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013