11/16/2012 - The following administrative change regarding the Specific Aims impacts the MedaMACS Protocol, Version Date 11/08/2011.  A letter from MedaMACS (date 11/16/2012) is attached to Protocol and must accompany the Protocol from this day forward.


List of Changes to the MedaMACS Protocol, Version Date 11/8/2011:

The following text, Section 2, Specific Aims, Aim 4 has been removed from the protocol:

“To develop and advance a team of emerging clinical investigators who will increase awareness of mechanical circulatory support and serve as role models for other young investigators.  

Hypothesis: Focused mentorship of early career investigators will foster the next generation of leaders in the clinical care of patients with advanced heart disease.

4.1.1     Junior investigators will take the lead in designing and analyzing research questions of their own with the mentorship of a more senior investigator at each clinical site.  Presentation of MedaMACS data at national meetings and manuscript development will be the responsibility of junior investigators.  A centralized publications committee with ensure equitable distribution of topics of interest so there is synergy across centers and appropriate extramural mentorship is available. 

4.1.2     Survey will be made among the young investigators for VAD-related publications, progression to independent research status, and affiliation to clinical VAD programs at 5 years after initiation of MedaMACS enrollment.”

MedaMACS continues to develop and advance a team of emerging clinical investigators to increase awareness of mechanical circulatory support and serve as role models for young investigators.  However, we feel that this can best be addressed in a separate format and should not be included in the study protocol.

MedaMACS Protocol