search
Back to results

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

Primary Purpose

Right Ventricular Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CentriMag RVAS placement
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Ventricular Failure focused on measuring Heart Failure, Right Ventricular Failure, Levitronix, Thoratec Corporation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Right ventricular failure from any cause

Exclusion Criteria:

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

Sites / Locations

  • Mayo Clinic Hospital Arizona
  • University of Kentucky
  • University of Minnesota
  • New York Columbia Presbyterian Hospital
  • University of Rochester Medical Center
  • Duke University Medical Center
  • University of Pittsburgh Medical Center
  • St. Luke's Episcopal Medical Center
  • Intermountain Medical Center
  • University of Utah

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment Group

Arm Description

Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Cardiac Index (CI)
Cardiac output (L/min) divided by the body surface area (m2)
Blood Urea Nitrogen (BUN)
BUN is a measure of renal function
Creatinine
Creatinine is a measure of renal function
Total Bilirubin
Total bilirubin is a measure of hepatic function

Full Information

First Posted
March 28, 2012
Last Updated
June 23, 2022
Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01568424
Brief Title
CentriMag RVAS U.S. Post-approval Study Protocol
Acronym
CMagRVAS
Official Title
CentriMag RVAS U.S. Post-approval Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricular Failure
Keywords
Heart Failure, Right Ventricular Failure, Levitronix, Thoratec Corporation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Other
Arm Description
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
Intervention Type
Device
Intervention Name(s)
CentriMag RVAS placement
Intervention Description
Patients will be treated with a CentriMag RVAS
Primary Outcome Measure Information:
Title
Survival
Description
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.
Time Frame
30 days post device removal
Secondary Outcome Measure Information:
Title
Central Venous Pressure (CVP)
Description
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.
Time Frame
Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal
Title
Mean Arterial Pressure (MAP)
Description
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.
Time Frame
Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.
Title
Cardiac Index (CI)
Description
Cardiac output (L/min) divided by the body surface area (m2)
Time Frame
Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.
Title
Blood Urea Nitrogen (BUN)
Description
BUN is a measure of renal function
Time Frame
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
Title
Creatinine
Description
Creatinine is a measure of renal function
Time Frame
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
Title
Total Bilirubin
Description
Total bilirubin is a measure of hepatic function
Time Frame
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Right ventricular failure from any cause Exclusion Criteria: Primary coagulopathy or platelet disorders Allergy or sensitivity to heparin and all alternative anticoagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Chatterjee
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
New York Columbia Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
St. Luke's Episcopal Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CentriMag RVAS U.S. Post-approval Study Protocol

We'll reach out to this number within 24 hrs