CentriMag RVAS U.S. Post-approval Study Protocol (CMagRVAS)

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

Study Overview

• Status: Completed
• Conditions: Right Ventricular Failure
• Intervention / Treatment: Device: CentriMag RVAS placement

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital Arizona
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New York
    • New York, New York, United States, 10032
      • New York Columbia Presbyterian Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Right ventricular failure from any cause

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Thoratec Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (ESTIMATE): April 2, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Thoratec Corporation; Levitronix; Right Ventricular Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: TC10152008