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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01999140
Other study ID # ICD Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2005
Est. completion date June 2030

Study information

Verified date April 2024
Source American College of Cardiology
Contact NCDR Product Support
Phone 1-800-257-4737
Email ncdr@acc.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1750
Est. completion date June 2030
Est. primary completion date June 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
United States American College of Cardiology/National Cardiovascular Data Registry (NCDR) Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
American College of Cardiology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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