Implantable Cardioverter Defibrillator (ICD Registry)

NCT01999140 | Recruiting DMC

• 1 other identifier: ICD Registry
• Study Type: observational
• Target: 1,750
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Primary prevention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All facilities performing ICD implants

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• American College of Cardiology: lead

Study Sites (1)

American College of Cardiology/National Cardiovascular Data Registry (NCDR)

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

NCDR Product Support

CONTACT

1-800-257-4737; ncdr@acc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: December 3, 2013
• Study Start: June 1, 2005
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (1)