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ICD Registry for Heart Conditions

This is an observational study, not a clinical trial testing a new treatment. It's called the ICD Registry and it collects information about patients who receive implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy devices with defibrillator (CRT-Ds). These devices are used to help manage heart conditions like heart failure and irregular heartbeats (ventricular arrhythmia). The study aims to understand how well these devices work and to track any complications that might occur after they are implanted. Hospitals submit data on patients who receive these devices, especially those insured by Medicare for primary prevention. The main goal is to look at complications and death rates from the time of the procedure until discharge, with data reported quarterly.

Study design
This is an observational study, not a randomized trial, involving an estimated 1750 participants. It collects real-world data on patients receiving ICDs and CRT-Ds.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Complications and death are measured from post-procedure until discharge, with data reported quarterly based on a rolling one year of data.

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NCT01999140

Implantable Cardioverter Defibrillator (ICD Registry)

Recruiting
Not specifiedAll AgesObservational
American College of Cardiology
~1,750 participants
Updated 2024-04-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Risk Adjusted Complications and Death Composite Measure
Measured over Post-procedure until discharge occurences. Reported quarterly based on a rolling 1 year of data.

Conditions

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

Explore related trials

Generalized ischemic myocardial dysfunctionHeart FailureVentricular Arrhythmia

Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

NCDR Product Support
[email protected]
1-800-257-4737
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Risk Adjusted Complications and Death Composite MeasurePost-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