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

This study has been completed.
Washington University School of Medicine
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University Identifier:
First received: June 8, 2009
Last updated: April 19, 2015
Last verified: April 2015

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.

Congestive Heart Failure
Sudden Cardiac Death

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

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

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

Enrollment: 630
Study Start Date: March 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

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
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Please refer to this study by its identifier: NCT00916435

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
Principal Investigator: Larisa G Tereshchenko, MD, PhD Johns Hopkins University
Principal Investigator: Ronald D Berger, MD, PhD Johns Hopkins University
  More Information


Responsible Party: Larisa Tereshchenko, Instructor of Medicine, Johns Hopkins University Identifier: NCT00916435     History of Changes
Other Study ID Numbers: 1K99HL094665-01 (in review)
Study First Received: June 8, 2009
Last Updated: April 19, 2015

Keywords provided by Johns Hopkins University:
Cardiac Arrest
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden processed this record on May 25, 2017