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

This study has been completed.
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00916435
First received: June 8, 2009
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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
Congestive Heart Failure
Sudden Cardiac Death
Arrhythmia
Cardiomyopathies

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:

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 The Johns Hopkins University School of Medicine
Principal Investigator: Ronald D Berger, MD, PhD The Johns Hopkins University School of Medicine
  More Information

Publications:

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), 1K99HL094665-01 (in review), NA_00016113
Study First Received: June 8, 2009
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014