← Back to searchRecruitingRecruiting
Implantable Cardioverter Defibrillator (ICD Registry)
NCT01999140 · American College of Cardiology
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
In January 2005 the Centers for Medicare and Medicaid Services (CMS) expanded the covered indications for primary prevention implantable cardioverter defibrillators (ICDs) to incorporate the findings from the Sudden Cardiac Death Heart Failure Trial (SCDHeFT) and the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). As part of this expansion, CMS mandated that a national registry be formed to compile data on Medicare patients implanted with primary prevention ICDs to confirm the appropriateness of ICD utilization in this patient population.
Responding to this mandate, a collaborative effort of the Heart Rhythm Society (HRS)and the American College of Cardiology Foundation (ACCF), utilizing the expertise of the National Cardiovascular Data Registry (NCDR®), developed the ICD Registry™. Enrollment opened on June 1, 2005. CMS selected the NCDR ICD Registry as the mandated national registry in October 2005.
Eligibility criteria
All U.S and International patients.
Inclusion Criteria:
* All patients who receive an ICD/CRT-D (initial or generator change) for primary or secondary prevention purposes.
* All patients with an ICD/CRT-D undergoing a Lead Only procedure.
* U.S. populations must submit all patients who receive an ICD/CRT-D (initial or generator change) for primary prevention purposes who are insured by Medicare.
Exclusion Criteria:
None
Study design
Enrollment target: 1750 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2005-06
Estimated completion: 2030-06
Last updated: 2024-04-18
Primary outcomes
- • Risk Adjusted Complications and Death Composite Measure (Post-procedure until discharge occurences. Reported quarterly based on a rolling 1 year of data.)
Sponsor
American College of Cardiology · other
Contacts & investigators
ContactNCDR Product Support · contact · ncdr@acc.org · 1-800-257-4737
All locations (1)
American College of Cardiology/National Cardiovascular Data Registry (NCDR)Recruiting
Washington D.C., District of Columbia, United States