Implantable Cardioverter Defibrillator (ICD Registry)

Recruiting

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

• Registration Number: NCT01999140
• Lead Sponsor: American College of Cardiology

Brief Summary

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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1750

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk Adjusted Complications and Death Composite Measure	Post-procedure until discharge occurences. Reported quarterly based on a rolling 1 year of data.	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

Trial Locations

Locations (1)

American College of Cardiology/National Cardiovascular Data Registry (NCDR); 🇺🇸 Washington, District of Columbia, United States