Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)
Study Status
Open to Enrollment
Study Description
Over the last two decades, mechanical circulatory support devices (MCSDs) have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, occasionally as a bridge to recovery, and most recently as permanent implantation or "destination therapy" for intractable heart failure. Although heart transplantation offers life-saving therapy for selected patients, its use is limited by a supply of donor organs that currently meets less than one-tenth the need. As a consequence, the number of MCSD implantations has increased in recent years, a trend that is expected to continue, especially in light of the Centers for Medicare and Medicaid Services' 2003 decision to provide reimbursement for MCSD implantation surgery.
INTERMACS is an observational registry of patients with end-stage heart failure who receive an FDA-approved MCSD. The purpose of this study is to collect and analyze clinical and laboratory data and tissue samples from patients who receive MCSDs as destination therapy for end-stage heart failure.
Despite favorable survival and quality of life outcomes, MCSDs do have severe and sometimes life-threatening complications, including infection, thrombosis and device failure. the development of new procedures and devices to reduce these complications will be expedited by the work of the INTERMACS registry involving the systematic, independent analysis of MCSD implantation procedures and outcomes. The National Heart, Lung and Blood Institute (NHLBI) will collaborate with the CMS and FDA in monitoring the work of the registry to permit the development of standard reporting of patient characteristics, indications, implantation procedures and adverse events. The investigators also plan to provide the registry resources to researchers outside the registry, and to publish and disseminate the study results.
Sponsor
National Heart, Lung and Blood Institute (NHLBI)
Key Eligibility
Inclusion criteria:
- Patients with an FDA-approved MCSD implanted on or after March 1, 2006. Every patient who has signed consent and has received an eligible MCSD at a participating center will be enrolled, regardless of the reason of implantation (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy)
- Eligible devices include all of the following:
- approved devices for any indications except through a registered clinical trial
- INTERMACS-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the INTERMACS framework
- external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group
- compassionate use of investigational devices or approved devices outside of approved indications or clinical trials
- Currently incarcerated
Principal Investigator
Contact
- Evelyn M. Horn, MD
- (212) 746-2381
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
