Study Results
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View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2009-09-30
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement
Patients will be treated with a CentriMag RVAS
Interventions
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CentriMag RVAS placement
Patients will be treated with a CentriMag RVAS
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergy or sensitivity to heparin and all alternative anticoagulants
ALL
No
Sponsors
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Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Pooja Chatterjee
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Mayo Clinic Hospital Arizona
Phoenix, Arizona, United States
University of Kentucky
Lexington, Kentucky, United States
University of Minnesota
Minneapolis, Minnesota, United States
New York Columbia Presbyterian Hospital
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
St. Luke's Episcopal Medical Center
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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TC10152008
Identifier Type: -
Identifier Source: org_study_id
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