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Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms (ICD-EGMs)

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ClinicalTrials.gov Identifier: NCT00916435
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University

Brief Summary:

The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:

  • to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
  • to predict progression of heart failure in patients with ICD.

Condition or disease
Congestive Heart Failure Sudden Cardiac Death Arrhythmia Cardiomyopathies

Study Type : Observational
Actual Enrollment : 630 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure
Study Start Date : March 2005
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources




Primary Outcome Measures :
  1. sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP) [ Time Frame: from enrollment up to 72 months ]

Secondary Outcome Measures :
  1. Composite heart failure outcome (HF hospitalization, HF death, heart transplant) [ Time Frame: from enrollment up to 72 months ]
  2. All-cause mortality [ Time Frame: from enrollment up to 72 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death
Criteria

Inclusion 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%
  • who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
  • undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD

Exclusion Criteria:

  • inability or unwillingness to provide valid informed consent
  • pregnancy
  • any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916435


Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Johns Hopkins University
Washington University School of Medicine
Investigators
Principal Investigator: Larisa G Tereshchenko, MD, PhD Johns Hopkins University
Principal Investigator: Ronald D Berger, MD, PhD Johns Hopkins University

Publications of Results:

Responsible Party: Larisa Tereshchenko, Instructor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00916435     History of Changes
Other Study ID Numbers: 1K99HL094665-01 (in review)
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Larisa Tereshchenko, Johns Hopkins University:
Arrhythmia
Cardiac Arrest
Cardiomyopathy
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden