Implantable Cardioverter Defibrillator (ICD Registry)

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1750

Contacts and Locations

• Study Contact: Name: NCDR Product Support; Phone Number: 1-800-257-4737; Email: ncdr@acc.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Recruiting
      • American College of Cardiology/National Cardiovascular Data Registry (NCDR)
      • Contact: NCDR Product Support; Phone Number: 800-257-4737; Email: ncdr@acc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All facilities performing ICD implants

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Primary prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Adjusted Complications and Death Composite Measure	Reported as one value for a composite measure looking at the following complications and death: Cardiac arrest, cardiac perforation, coronary venous dissection, hemothorax, device-related infection, lead dislodgement, mortality, myocardial infarction, pericardial tamponade, pneumothorax, stroke/transischemic attack (TIA), urgent cardiac surgery, hematoma, set screw problem	Post-procedure until discharge occurences. Reported quarterly based on a rolling 1 year of data.

Collaborators and Investigators

• Sponsor: American College of Cardiology

Publications and helpful links

Helpful Links

• The link will provide further information about the ICD Registry as well as related research and publications.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimated): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: ICD Registry