Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with advanced heart failure.
Collect and analyze clinical and laboratory data from patients who are receiving mechanical circulatory support devices (MCSD) for end-stage heart failure. [ Time Frame: Collected as part of the registry ]
Biospecimen Retention: Samples With DNA
DNA sample collection was an optional portion of the project during the first contract period (2005-2010). Tissue and Blood specimens were collected at the time of implant, explant or exchange of the mechanical circulatory assist device. Intermacs no longer collects blood or tissue specimens.
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with end-stage heart failure that receive a legally utilized mechanical circulatory support device.
Legally utilized 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