Heart Failure Clinical Trial
Official title:
Implantable Cardioverter Defibrillator (ICD Registry)
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | American College of Cardiology/National Cardiovascular Data Registry (NCDR) | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
American College of Cardiology |
United States,
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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