Right Ventricular FailureCMagRVASNCT01568424
CentriMag RVAS U.S. Post-approval Study Protocol
A study testing CentriMag RVAS placement in people with Right Ventricular Failure, run by Abbott Medical Devices at 10 sites in United States.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Right Ventricular Failure
- What is being tested?
- CentriMag RVAS placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Right ventricular failure from any cause
Who cannot join
- Primary coagulopathy or platelet disorders
- Allergy or sensitivity to heparin and all alternative anticoagulants
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Duke University Medical Center
Durham, North Carolina, 27710
St. Luke's Episcopal Medical Center
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536
University of Minnesota
Minneapolis, Minnesota, 55455
Intermountain Medical Center
Murray, Utah, 84107
New York Columbia Presbyterian Hospital
New York, New York, 10032
Mayo Clinic Hospital Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84132
About this study
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
Read the 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:
- 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.
- Conditions
- Right Ventricular Failure
- Being tested
- CentriMag RVAS placement
- Keywords
- Heart Failure, Right Ventricular Failure, Levitronix, Thoratec Corporation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentriMag RVAS placementDevice
Patients will be treated with a CentriMag RVAS
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Other | Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life. Receives: Device: CentriMag RVAS placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post device removal
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startSep 2009
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Right Ventricular FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Pooja Chatterjee, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568424
- Sponsor's protocol ID
- TC10152008
- Acronym
- CMagRVAS
- Status last verified
- Jun 2022
- First submitted
- 28 Mar 2012
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CentriMag RVAS U.S. Post-approval Study Protocol
- ClinicalTrials.gov ID
- NCT01568424
- Acronym / sponsor ID
- CMagRVAS / TC10152008
- Conditions
- Right Ventricular Failure
- Keywords
- Heart Failure, Right Ventricular Failure, Levitronix, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- Sep 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Other | Device: CentriMag RVAS placementPatients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Right ventricular failure from any cause
Key exclusion criteria (2 listed)
- Primary coagulopathy or platelet disorders
- Allergy or sensitivity to heparin and all alternative anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CentriMag RVAS placementPatients will be treated with a CentriMag RVAS | Device | Treatment Group |
Primary outcome
Survival
Time frame: 30 days post device removal
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.
6 secondary outcomes
Central Venous Pressure (CVP)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
Creatinine
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
Total Bilirubin
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Chatterjee study director
Abbott Medical Devices
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CentriMag RVAS placement in people with Right Ventricular Failure, run by Abbott Medical Devices at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 30 days post device removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.