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Interagency Registry
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All Things INTERMACS® |
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Conflict of Interest Disclosure |
FAQs
What is INTERMACS® (Interagency Registry for Mechanically Assisted Circulatory Support)?
INTERMACS® is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives.
Who sponsors INTERMACS®?
This project has been funded in whole or in part with federal funds from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), and the Department of Health and Human Services (HHS) under Contract Number N01-HV-58198.
The
Why is INTERMACS® important?
The objectives of INTERMACS® include, but are not limited to the following:
Who is eligible to participate in INTERMACS®?
Any
medical center in the
What are the benefits of participating in INTERMACS®?
Participating in this registry will meet the CMS and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) reporting requirement that…"requires submission to a national audited registry of health data on all VAD destination therapy patients from the date of implantation throughout the remainder of their lives." Ongoing certification of VAD programs and program staff require documentation of volume and outcomes which encompass both investigational and approved VADs. INTERMACS® is the only registry that meets the stringent data reporting requirement of CMS and JCAHO, and will require inclusion of all patients implanted with devices designed for chronic implantation, regardless of initial intent. INTERMACS is designed to simplify reporting of the essential outcome data and provide center-specific analyses for required quality improvement.
Are all medical centers implanting mechanical assist devices required to participate in INTERMACS®?
Participation in INTERMACS® is not mandatory. If you do choose to participate, you will be expected to adhere to the requirements for submission of patient data. Periodic audits will be conducted to assure that all VAD patients are entered, data submissions are complete and submitted in a timely manner.
Is IRB approval required to participate in INTERMACS®?
Your hospital’s Institutional Review Board (IRB) must review this registry before you will be permitted to submit patient data to INTERMACS®. If your IRB approves your application for participation in this registry, you must submit documentation of that decision to INTERMACSSUPPORT. Your facility is responsible for obtaining and maintaining all patient consents and all IRB documentation. Your center will not be activated in INTERMACS® until IRB approval has been submitted.
If we have IRB approval for current participation in the ISHLT MCSD Registry, will it transfer to INTERMACS®?
No, your Institutional Review Board will have to approve your participation in INTERMACS®. The databases are very different in both the time points for reporting and the scope of the questions.
How do I enroll in INTERMACS®?
Enrollment formats are available under new site enrollment.
Directions for accessing the enrollment formats have also been provided in this invitation packet.
Will training be provided for my staff?
Yes, you are required to send at least one staff member (but not more than two) for training on all aspects of INTERMACS®. The Coordinator Training will be held prior to the launch date for the registry. Additionally, you must identify a Principal Investigator from your facility and we strongly encourage your PI to attend our one day training session. It will be held in conjunction with the Coordinator Training session.
When will the INTERMACS® database go live?
The INTERMACS® database is live and ready for patient entry.
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