CentriMag RVAS U.S. Post-approval Study Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01568424
First received: March 28, 2012
Last updated: March 25, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CentriMag RVAS U.S. Post-approval Study Protocol

Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Survival [ Time Frame: 30 days post device removal ] [ Designated as safety issue: Yes ]

    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:
  • Hemodynamics [ Time Frame: Expected average of 14 days during device use; 2 days post device removal ] [ Designated as safety issue: Yes ]
    Reductions in MAP/CVP

  • End organ function [ Time Frame: Expected average of 14 days during device use; 2 days post device removal ] [ Designated as safety issue: Yes ]
    Reductions in creatinine and BUN; Reductions in Total Bilirubin

  • Adverse Effects [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Acceptable incidence of adverse effects

  • Hemodynamics [ Time Frame: Expected average of 14 days during device use; 2 days post device removal ] [ Designated as safety issue: Yes ]
    Increases in MAP and cardiac index


Enrollment: 25
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01568424     History of Changes
Other Study ID Numbers: TC10152008
Study First Received: March 28, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thoratec Corporation:
Heart Failure
Right Ventricular Failure
Levitronix

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014