Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

Description

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

Conditions

Heart Failure, Congestive, Death, Sudden, Cardiac, Arrhythmia, Cardiomyopathies

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Study Overview

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Study Details

Study overview

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

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

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

Condition
Heart Failure, Congestive
Intervention / Treatment

-

Contacts and Locations

Washington

Washington Hospital Center, Washington, District of Columbia, United States, 20010

Baltimore

University of Maryland Medical Center, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States, 21205

Richmond

Virginia Commonwealth University School of Medicine, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

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

Study Record Dates

2029-03