Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

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 INTERMACSĀ®; and
4. Serving as a scalable data infrastructure for pre and post market studies.

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Currently incarcerated

National Heart, Lung, and Blood Institute

Dates: 01/27/2011 - 11/30/2015

Last Updated: 12/04/2016

Study HIC#: 0911006005REG

Get Involved

For more information about this study, contact:
Lynn Marie Wilson
203-737-8871
lynn.wilson@ynhh.org

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigator

Abeel Mangi

Principal Investigator