RecruitingNCT00733590

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)


Sponsor

Johns Hopkins University

Enrollment

1,500 participants

Start Date

Jun 1, 2003

Study Type

OBSERVATIONAL

Conditions

Summary

The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to : 1. to gain a better understanding of the biological mechanisms that predispose to SCD 2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is observing people who have a heart device called an ICD (implantable cardioverter-defibrillator) — a small device in the chest that delivers electric shocks to prevent sudden cardiac death — to learn how well it works over time. **You may be eligible if...** - You have had a heart attack at least 4 weeks ago, or have had weak heart muscle for at least 9 months due to a non-heart-attack cause - Your heart pumps at 35% or less of its normal capacity (low ejection fraction) - You recently had your ICD battery replaced (within the last 24 months) as a preventive measure against sudden cardiac death - Your ICD was implanted to prevent a first cardiac arrest (primary prevention) **You may NOT be eligible if...** - Your ICD was implanted after you already survived a cardiac arrest (secondary prevention) - You are unable or unwilling to give consent - You have severe heart failure (New York Heart Association Class IV — unable to do any activity without discomfort) - You already needed a pacemaker for rhythm problems before getting the ICD Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

Washington Hospital Center

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

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States

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NCT00733590


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