Implantable Cardioverter Defibrillator (ICD Registry)

Heart Failure Clinical Trial

Official title:

Implantable Cardioverter Defibrillator (ICD Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999140
• Other study ID #: ICD Registry
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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.

External Links

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