Trial Purpose and Description
The purposes of INTERMACS include:
1. Collecting pertinent and standardized patient demographic, clinical and device related data elements from participating hospitals to measure and assess the quality of care and outcomes for patients receiving MCSDs;
2. Providing confidential periodic reports to the participating hospitals, government agencies, and industrial partners to improve the quality of care of patients receiving mechanical circulatory support and to evaluate the effectiveness and optimal utilization and performance of these devices;
3. Fostering collaborative research based upon the data collected by means of INTERMACS®; and
4. Serving as a scalable data infrastructure for pre and post market studies.
- FDA approved MCSD implanted on or after March 1, 2006; every consented patient who receives an eligible MCSD at a participating center will be enrolled, regardless of reason (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy). Beginning June 1, 2014, and with lnstitutional Review Board approval, participating sites may enroll patients under a waiver of informed consent and authorization.
- Eligible devices include all of the following: 1) approved devices for any indications; 2) Intermacs-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the Intermacs framework; 3) external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group; 4) compassionate use of investigational devices or approved devices outside of approved indications or clinical trials
- Currently incarcerated
National Heart, Lung, and Blood Institute
Dates: 01/27/2011 - 11/30/2015
Last Updated: 12/04/2016
Study HIC#: 0911006005REG