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Recruiting

NCT Number: NCT01999140

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

Location status: Recruiting

Location contact

NCDR Product Support

CONTACT

[email protected]

800-257-4737

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Risk Adjusted Complications and Death Composite Measure

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

NCDR Product Support

CONTACT

[email protected]

1-800-257-4737

Sponsors and collaborators

Lead sponsor

American College of Cardiology

Other

Registry information

Important dates

Study start
2005
Primary completion
2030
Study completion
2030
First posted
Dec 3, 2013
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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