N/A
N=25
CentriMag RVAS U.S. Post-approval Study Protocol
Right Ventricular Failure
Bottom Line
View on ClinicalTrials.gov: NCT01568424 ↗Enrolled (actual)
25
Serious AEs
96.0%
Results posted
Apr 2017
Primary outcome: Primary: Survival — 80 percentage of survival at 30 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CentriMag RVAS placement (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
80 | — |
| SECONDARY Central Venous Pressure (CVP) |
11; 11; 10; 12; 11; 10 | — |
| SECONDARY Mean Arterial Pressure (MAP) |
72; 74; 74; 75; 79; 77 | — |
| SECONDARY Cardiac Index (CI) |
2.4; 2.2; 2.9; 3.0; 7.7; 2.7 | — |
| SECONDARY Blood Urea Nitrogen (BUN) |
27; 27; 26; 33; 28; 22 | — |
| SECONDARY Creatinine |
1.4; 1.3; 1.1; 1.2; 1.0; 1.0 | — |
| SECONDARY Total Bilirubin |
1.1; 3.0; 3.0; 2.8; 1.8; 1.3 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01568424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.