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CentriMag RVAS U.S. Post-approval Study Protocol (CMagRVAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01568424
First Posted: April 2, 2012
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Corporation )
  Purpose
The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause

Condition Intervention
Right Ventricular Failure Device: CentriMag RVAS placement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CentriMag RVAS U.S. Post-approval Study Protocol

Further study details as provided by St. Jude Medical ( Thoratec Corporation ):

Primary Outcome Measures:
  • Survival [ Time Frame: 30 days post device removal ]

    In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer).

    In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant.



Secondary Outcome Measures:
  • Central Venous Pressure (CVP) [ Time Frame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal ]
    CVP is a measure of right heart filling pressure, or the preload to the right ventricle. During RVAD support, the CVP decreases as blood is drawn into the pump and then ejected into the pulmonary artery.

  • Mean Arterial Pressure (MAP) [ Time Frame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal. ]
    MAP is the mean value for the blood pressure in the arterial circulation. During RVAD support, this value provides information regarding the adequacy of cardiac output from the left ventricle.

  • Cardiac Index (CI) [ Time Frame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal. ]
    Cardiac output (L/min) divided by the body surface area (m2)

  • Blood Urea Nitrogen (BUN) [ Time Frame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal ]
    BUN is a measure of renal function

  • Creatinine [ Time Frame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal ]
    Creatinine is a measure of renal function

  • Total Bilirubin [ Time Frame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal ]
    Total bilirubin is a measure of hepatic function


Enrollment: 25
Study Start Date: September 2009
Study Completion Date: June 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Group
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
Device: CentriMag RVAS placement
Patients will be treated with a CentriMag RVAS

Detailed Description:

Objectives of this study are to evaluate:

  1. Duration of right ventricular support
  2. Incidence of adverse effects
  3. Evaluation of end-organ function
  4. Evaluation of hemodynamics
  5. Survival at 30 days post RVAD removal

The primary endpoints include:

  1. In patients who recover and do not go on to transplantation or a long-term device:

    a. Survival to 30 days post-support or to hospital discharge (whichever is longer)

  2. In patients who do not recover and are bridged to transplant or a long-term system:

    1. Survival to induction of anesthesia for implantation of a long-term mechanical support device or heart transplant

Secondary endpoints include:

  1. On Pump Hemodynamics

    1. A clearly observable trend toward reduction of mean right atrial pressure / central venous pressure is demonstrated while the patient is on support compared to baseline.
    2. A clearly observable trend toward an increase in mean arterial pressure is demonstrated while the patient is on support compared to baseline
    3. A clearly observable trend toward an increase in mean cardiac index is demonstrated while the patient is on support compared to baseline
  2. Post Pump Hemodynamics (must meet at least two of the following criteria)

    1. Based on plotting of the data, success will be achieved if a clearly observable trend toward reduction of mean right atrial pressure/central venous pressure is demonstrated after device removal compared to baseline
    2. Based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean arterial pressure is demonstrated after device removal compared to baseline
    3. Based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean cardiac index is demonstrated after device removal compared to baseline
  3. A clearly observable trend toward a reduction in creatinine and/or BUN while on support and after device removal compared to baseline
  4. A clearly observable trend toward a reduction in total bilirubin while on support and after device removal compared to baseline
  5. An acceptable incidence of adverse effects observed

Patient Population

This study includes data from 25 consecutive patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Right ventricular failure from any cause

Exclusion Criteria:

  • Primary coagulopathy or platelet disorders
  • Allergy or sensitivity to heparin and all alternative anticoagulants
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568424


Locations
United States, Arizona
Mayo Clinic Hospital Arizona
Phoenix, Arizona, United States, 85054
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
New York Columbia Presbyterian Hospital
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
St. Luke's Episcopal Medical Center
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Thoratec Corporation
Investigators
Study Director: Mark Macedo, BSN St. Jude Medical
  More Information

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01568424     History of Changes
Other Study ID Numbers: TC10152008
First Submitted: March 28, 2012
First Posted: April 2, 2012
Results First Submitted: March 3, 2017
Results First Posted: April 17, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by St. Jude Medical ( Thoratec Corporation ):
Heart Failure
Right Ventricular Failure
Levitronix
Thoratec Corporation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases