Implantable Cardioverter Defibrillator (ICD Registry)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2030-06-30

Brief Summary

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The ICD Registry™ is a nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry captures the characteristics, treatments, and outcomes of patients receiving (ICDs). Patient-level data is submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to both a volume peer group (number of ICD patients submitted annually) and the entire ICD registry data set.

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Detailed Description

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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.

Conditions

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Heart Failure Nonischemic Cardiomyopathy Ischemic Cardiomyopathy Ventricular Arrhythmia Complications; Device, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary prevention

No interventions assigned to this group

Eligibility Criteria

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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.