CentriMag RVAS U.S. Post-approval Study Protocol

CentriMag RVAS U.S. Post-approval Study Protocol

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

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.

Inclusion Criteria:

• Right ventricular failure from any cause

Exclusion Criteria:

• Primary coagulopathy or platelet disorders
• Allergy or sensitivity to heparin and all alternative anticoagulants