Clinical trial NCT01999140: Implantable Cardioverter Defibrillator (ICD Registry)
Official title: Implantable Cardioverter Defibrillator (ICD Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Nonischemic Cardiomyopathy
Ischemic Cardiomyopathy
Ventricular Arrhythmia
Complications; Device, Cardiac
Lead sponsor: American College of Cardiology
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 1750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All facilities performing ICD implants

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk Adjusted Complications and Death Composite Measure
timeFrame: Post-procedure until discharge occurences. Reported quarterly based on a rolling 1 year of data.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: American College of Cardiology/National Cardiovascular Data Registry (NCDR)
state: District of Columbia
Study officials:
References: