CentriMag RVAS U.S. Post-approval Study Protocol

Study Overview
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Brief Summary
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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
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Objectives of this study are to evaluate: Duration of right ventricular support Incidence of adverse effects Evaluation of end-organ function Evaluation of hemodynamics Survival at 30 days post RVAD removal The primary endpoints include: 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) 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 mechanical support device or heart transplant Secondary endpoints include: On Pump Hemodynamics 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. A clearly observable trend toward an increase in mean arterial pressure is demonstrated while the patient is on support compared to baseline A clearly observable trend toward an increase in mean cardiac index is demonstrated while the patient is on support compared to baseline Post Pump Hemodynamics (must meet at least two of the following criteria) 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 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 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 A clearly observable trend toward a reduction in creatinine and/or BUN while on support and after device removal compared to baseline A clearly observable trend toward a reduction in total bilirubin while on support and after device removal compared to baseline 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.

Official Title
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CentriMag RVAS U.S. Post-approval Study Protocol

Conditions
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Right Ventricular Failure

Intervention / Treatment
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* Device: CentriMag RVAS placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Right ventricular failure from any cause Exclusion Criteria: Primary coagulopathy or platelet disorders Allergy or sensitivity to heparin and all alternative anticoagulants
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment Group<br>Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life. | Device: CentriMag RVAS placement<br>* Patients will be treated with a CentriMag RVAS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | 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. | 30 days post device removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Venous Pressure (CVP) | 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. | Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal | 
| Mean Arterial Pressure (MAP) | 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. | Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal. | 
| Cardiac Index (CI) | Cardiac output (L/min) divided by the body surface area (m2) | Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal. | 
| Blood Urea Nitrogen (BUN) | BUN is a measure of renal function | 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 | Creatinine is a measure of renal function | 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 | Total bilirubin is a measure of hepatic function | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Right Ventricular Failure, Levitronix, Thoratec Corporation