|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
H070004 / PAS001 |
| Date Original Protocol Accepted |
10/07/2008
|
| Date Current Protocol Accepted |
05/22/2009
|
| Study Name |
Centrimag PAS
|
| Device Name |
CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, one-armed, multi-center observational study. This study will include data from 25 consecutive patients from the participating clinical centers with acute nght ventricular failure from any cause requiring use of the CentnMag RVAS to sustain life Patients may be enrolled from two populations The first population will include any patient in need of an RVAD that is not participating in the Levitronix
pivotal study entitled, "Levitronix CentnMag VAS Failure-to-Wean from Cardiopulmonary Bypass Trial" The second population will include patients who have been enrolled in the Levitronix pivotal trial and subsequently enrolled into this post approval study Patients enrolled in the pivotal study will already have a CentnMag RVAS in place
|
| Study Population |
The study population includes patients implanted with the dentrimag device. The CentriMag RVAS is intended to provide temporary circulatory support for up to 14 days for patients in cardiogenic shock due to right ventricular failure. It is intended for use in patients with a body surface area of 1.4 m2 or greater.
|
| Sample Size |
25 consecutive patients implanted with the device will be followed from device implant to device removal, and 30 days post RVAD removal.
|
| Key Study Endpoints |
The primary endpint in patients who recover and do not go on to transplantation or use of a long-term device includes 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 the primary endpoint is survival to induction of anesthesia for implantation of a long-term device or heart transplant.
|
| Follow-up Visits and Length of Follow-up |
Clinical endpoints will be recorded at baseline, 3 days post-implant, prior to explant, and 30 days post-removal of the device.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
25
|
| Actual Number of Sites Enrolled |
9
|
| Patient Follow-up Rate |
100%
|
| Final Safety Findings |
Central venous pressure, mean arterial pressure, and cardiac index increased a little on-pump, but returned to baseline by 2 days post-쳌pump.
BUN and total bilirubin increased on-pump, but returned below baseline within 30 days post-pump.
|
| Final Effect Findings |
Success rate (Survival to 30 days, transplanted, or bridged to artificial heart): 72%
|
| Study Strengths & Weaknesses |
Strengths: Prospective follow-up study 100% follow-up
Performance goal met by large margin
(72% vs. 10% performance goal) Weaknesses: None significant
|
| Recommendations for Labeling Changes |
NONE
|
