CentriMag RVAS U.S. Post-approval Study Protocol
This study is currently recruiting participants.
Verified May 2013 by Thoratec Corporation
Sponsor:
Thoratec Corporation
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01568424
First received: March 28, 2012
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Right Ventricular Failure |
Device: CentriMag RVAS placement |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CentriMag RVAS U.S. Post-approval Study Protocol |
Further study details as provided by Thoratec Corporation:
Primary Outcome Measures:
- Survival [ Time Frame: 30 days post device removal ] [ Designated as safety issue: Yes ]
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:
- Hemodynamics [ Time Frame: Expected average of 14 days during device use; 2 days post device removal ] [ Designated as safety issue: Yes ]Reductions in MAP/CVP
- End organ function [ Time Frame: Expected average of 14 days during device use; 2 days post device removal ] [ Designated as safety issue: Yes ]Reductions in creatinine and BUN; Reductions in Total Bilirubin
- Adverse Effects [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]Acceptable incidence of adverse effects
- Hemodynamics [ Time Frame: Expected average of 14 days during device use; 2 days post device removal ] [ Designated as safety issue: Yes ]Increases in MAP and cardiac index
| Estimated Enrollment: | 25 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568424
Contacts
| Contact: Mark Macedo | mmacedo@thoratec.com |
Locations
| United States, Arizona | |
| Mayo Clinic Hospital Arizona | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Marlene Lind lind.marlene@mayo.edu | |
| Principal Investigator: Octavio Pajaro, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Carol Toninato ctoninato@umphysicians.umn.edu | |
| Principal Investigator: Ranjit John, MD | |
| United States, New York | |
| New York Columbia Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Kathy Idrissi kc286@columbia.edu | |
| Principal Investigator: Hiroo Takayama, MD | |
| University of Rochester Medical Center | Completed |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Han Billard han.billard@duke.edu | |
| Principal Investigator: Carmelo Milano, MD | |
| United States, Texas | |
| St. Luke's Episcopal Medical Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Felicia Frank ffrank@heart.thi.tmc.edu | |
| Principal Investigator: William Cohn, MD | |
| United States, Utah | |
| Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84107 | |
| Contact: Marsha Eidson marsha.eidson@imail.org | |
| Principal Investigator: Stephen Clayson, MD | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Erin Davis erin.davis@hsc.utah.edu | |
| Principal Investigator: Craig Selzman, MD | |
Sponsors and Collaborators
Thoratec Corporation
More Information
No publications provided
| Responsible Party: | Thoratec Corporation |
| ClinicalTrials.gov Identifier: | NCT01568424 History of Changes |
| Other Study ID Numbers: | TC10152008 |
| Study First Received: | March 28, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Thoratec Corporation:
|
Heart Failure Right Ventricular Failure Levitronix |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 13, 2013