CentriMag RVAS U.S. Post-approval Study Protocol
- Conditions
- Right Ventricular Failure
- Interventions
- Device: CentriMag RVAS placement
- Registration Number
- NCT01568424
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Right ventricular failure from any cause
- Primary coagulopathy or platelet disorders
- Allergy or sensitivity to heparin and all alternative anticoagulants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group CentriMag RVAS placement Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
- Primary Outcome Measures
Name Time Method Survival 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
Name Time Method Central Venous Pressure (CVP) 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) 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) 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) 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 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 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
Trial Locations
- Locations (10)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Mayo Clinic Hospital Arizona
🇺🇸Phoenix, Arizona, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
St. Luke's Episcopal Medical Center
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
New York Columbia Presbyterian Hospital
🇺🇸New York, New York, United States