Back to search results

Observational Study of ICDs for Sudden Cardiac Death Prevention

This study is looking at how internal defibrillators (ICDs) help prevent sudden cardiac death (SCD) in people with heart failure or cardiomyopathy. Researchers want to understand why some people with ICDs still experience SCD, even when their device is working correctly. They are observing patients who have already received an ICD replacement for primary prevention of SCD. The study aims to identify subtle differences in the heart's structure and function that might put someone at higher risk for SCD. Success in this study means identifying factors that predict who is most likely to benefit from an ICD. The study is currently enrolling about 1500 participants aged 18 to 85 who have had a heart attack at least 4 weeks ago, have weak heart muscle (ejection fraction of 35% or less), and have received an ICD replacement within the last 24 months.

Study design
This is an observational study involving about 1500 participants. It compares patients who experience sudden cardiac death (as detected by their ICD) to those who do not.
What's involved
Participants will be followed over time, and researchers will collect information on their clinical status, ECGs (heart tracings), and genetic and protein markers.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years to track occurrences of arrhythmic sudden death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00733590

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

Recruiting
Not specifiedAges 18–85Observational
Johns Hopkins University
~1,500 participants
Updated 2026-01-20 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD
Measured over 10 years

Conditions

Heart Failure, Congestive
Death, Sudden, Cardiac
Arrhythmia
Cardiomyopathies

Explore related trials

ArrhythmiaCardiomyopathyHeart FailureSudden Cardiac Death

Where it's being run

4 sites across 3 states
Maryland2
District of Columbia1
Virginia1

Study leadership

  • Katherine C Wu, MD · PRINCIPAL_INVESTIGATOR · Associate Professor of Medicine Johns Hopkins University

Who to contact

Katherine Wu, MD
[email protected]
410-502-7283
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

History of acute MI at least 4 weeks old
Non-ischemic LV dysfunction for at least 9 months
Who have an ejection fraction (EF) \< or = to 35%
Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.
Who have primary prevention implants.

Exclusion

ICD generator replacement for secondary prevention
Inability or unwillingness to provide valid informed consent
New York Heart Association Class IV heart failure
Patients with pre-existing Class 1 indications for pacemaker therapy.

What this trial measures

  • Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD10 years