Actively Recruiting

All Genders
ID01999140

Implantable Cardioverter Defibrillator (ICD) Registry to Track Patient Outcomes and Device Use

Led by American College of Cardiology · Updated on 2024-04-18

1750

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The ICD Registry is a nationwide program designed to help hospitals track and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillators (CRT-Ds). It collects detailed data on patient characteristics, treatments, and outcomes to ensure appropriate use of these devices, especially following expanded coverage indications by Medicare for primary prevention. This registry was established in response to a mandate by the Centers for Medicare and Medicaid Services (CMS) to monitor ICD use in Medicare patients after important clinical trial findings. The registry collects patient-level data from participating hospitals quarterly, which is submitted to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). This data includes patients receiving ICDs or CRT-Ds for both primary and secondary prevention, including initial implants, generator changes, and lead-only procedures. The NCDR then produces an Outcomes Report comparing each hospital's data to peer groups and the overall registry dataset. Participants in the registry have their post-procedure complications and death rates tracked from the time of device implantation until hospital discharge, with reports generated quarterly based on rolling yearly data. The registry continuously monitors outcomes to support quality improvement in ICD and CRT-D care. Enrollment began in June 2005, and the program continues to collect data to enhance patient safety and treatment effectiveness over time.

CONDITIONS

Brief Title

Implantable Cardioverter Defibrillator (ICD Registry)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients who receive an ICD or CRT-D device (initial implant or generator change) for primary or secondary prevention.
  • Patients with an ICD or CRT-D undergoing a lead-only procedure.
  • U.S. patients insured by Medicare receiving an ICD or CRT-D for primary prevention must be submitted.
  • Patients from all U.S. and international locations are eligible.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implantation and Immediate Post-procedure Monitoring

Duration - Post-procedure until discharge

Participants undergo implantation of an ICD or CRT-D device and are monitored for complications and outcomes until hospital discharge.

1 hospital stay including the implantation procedure and monitoring

Long-term Monitoring

Duration - Up to 25 years

Participants are followed to track patient outcomes and device use over time.

Periodic follow-up visits as part of routine care

Trial Site Locations

Total: 1 location

1

American College of Cardiology/National Cardiovascular Data Registry (NCDR)

Washington D.C., District of Columbia, United States, 20037

Actively Recruiting

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Research Team

N

NCDR Product Support

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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