Implantable Cardioverter Defibrillator (ICD Registry)

American College of Cardiology

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT01999140

ICD Registry

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,750 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,750 participants in 1 patient group

Primary prevention