CentriMag RVAS U.S. Post-approval Study Protocol

Right Ventricular Failure Clinical Trial

— CMagRVAS  

Official title:

CentriMag RVAS U.S. Post-approval Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568424
• Other study ID #: TC10152008
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: June 2014

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Right ventricular failure from any cause

Exclusion Criteria:

• Primary coagulopathy or platelet disorders

• Allergy or sensitivity to heparin and all alternative anticoagulants

Related Conditions & MeSH terms

• Heart Failure
• Right Ventricular Failure

Intervention

Device:
• CentriMag RVAS placement
Patients will be treated with a CentriMag RVAS

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Luke's Episcopal Medical Center	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	New York Columbia Presbyterian Hospital	New York	New York
United States	Mayo Clinic Hospital Arizona	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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