Clinical trial NCT01568424: CentriMag RVAS U.S. Post-approval Study Protocol
Official title: CentriMag RVAS U.S. Post-approval Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Right Ventricular Failure
Keywords: Heart Failure
Right Ventricular Failure
Levitronix
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2012-04-02
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Survival
timeFrame: 30 days post device removal
Secondary outcomes:
measure: Central Venous Pressure (CVP)
timeFrame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal
measure: Mean Arterial Pressure (MAP)
timeFrame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.
measure: Cardiac Index (CI)
timeFrame: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.
measure: Blood Urea Nitrogen (BUN)
timeFrame: 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
measure: Creatinine
timeFrame: 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
measure: Total Bilirubin
timeFrame: 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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital Arizona
state: Arizona
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: New York Columbia Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: St. Luke's Episcopal Medical Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Abbott Medical Devices
name: Pooja Chatterjee
role: STUDY_DIRECTOR
References: